Where To Buy Hydroquinone
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We have discontinued our Ambi Fade Cream Normal and Ambi Fade Cream Oily formulated with hydroquinone. This ingredient is no longer available over the counter and can only be prescribed by a licensed Board certified dermatologist. Ambi is excited to bring to the market a NEW clinically-studied hydroquinone-free Fade Collection.
We have discontinued our Ambi Fade Cream Normal and Ambi Fade Cream Oily formulated with 2% Hydroquinone. Per the FDA, products with the ingredient hydroquinone can no longer be available to consumers over the counter and can only be prescribed by a licensed board-certified Dermatologist. Ambi is excited to bring to the market three NEW clinically-studied hydroquinone-free Fade Collection.
[4/19/2022] FDA issued warning letters to 12 companies for selling over-the-counter (OTC) skin lightening products containing hydroquinone that do not meet the requirements to be legally sold as OTC drugs. The warning letters explain that these OTC skin lightening products containing the active drug ingredient hydroquinone are unapproved drugs and are not generally recognized as safe and effective (not GRASE).
FDA has received reports of serious side effects including skin rashes, facial swelling, and ochronosis (discoloration of skin) from the use of skin lightening products containing hydroquinone. FDA advises consumers not to use these products due to the potential harm they may cause, including ochronosis which may be permanent. Consumers should talk to their health care professional about treatment options for certain skin conditions including aged or dark spots.
Currently, Tri-Luma is the only FDA-approved drug containing hydroquinone. Tri-Luma is a prescription product approved for the short-term treatment of dark spots associated with moderate-to-severe melasma of the face. Tri-Luma should only be used under the supervision of a licensed health care professional.
In addition to the COVID-19 response efforts, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) included important reforms that modernized the way certain OTC drugs are regulated. This reform finalized the legal status of products with certain active ingredients or other conditions that had been pending under the previous rulemaking framework, including finalizing the status of OTC skin lightening products. As a result, since enactment of the CARES Act, OTC skin lightening products containing hydroquinone are deemed to be new drugs and are misbranded. All OTC skin lightening products require an FDA approved new drug application before they can be legally marketed.
As a result of CARES Act, effective September 23, 2020, manufacturers and distributors of OTC skin lightening products that do not have FDA approval must remove the products from the marketplace. The warning letters FDA issued today are to companies still marketing OTC skin lightening products containing hydroquinone without an FDA approved new drug application.
Hydroquinone is marketed most aggressively to women of color for its whitening ability in skin creams. The chemical is allowed in personal care products in the United States in concentrations up to two percent. Although banned in the European Union, a UK news report found that products containing hydroquinone were relatively easy to procure.[1]
In addition to its use in skin lighteners, hydroquinone is a possible impurity of tocopheryl acetate[2] (synthetic Vitamin E) which is very common in facial and skin cleansers, facial moisturizers and hair conditioners.
Respiratory Tract Irritation: Hydroquinone may be harmful if inhaled, causing irritation of the nose, throat and upper respiratory tract. A study on occupational exposure of hydroquinone showed that subjects exposed to hydroquinone had a higher prevalence of a cough and decreased lung capacity compared to their unexposed counterparts.[6]
Banned from cosmetics in the European Union; restricted use in Canadian cosmetics. The U.S. Cosmetics Ingredients Review Panel indicates that hydroquinone is unsafe for use in products that are left on the skin, but because of lax enforcement, directions for skin-lightening products containing hydroquinone encourage frequent and consistent use on the skin.[7][8][9] It has been recommended to the National Toxicology Program (NTP) for further studies. The FDA continues to allow the availability of products containing hydroquinone in OTC drugs.
Melanocytes synthesize melanin from an important amino acid, tyrosine. The conversion of tyrosine to skin pigmentation requires several enzymatic steps; hydroquinone targets tyrosine hydroxilase, which converts tyrosine to dihydroxyphenylalanine, the most immediate melanin precursor.[10][11]
Yes. Due to rising concerns among the medical community and the publication of research that linked hydroquinone to higher cancer risks in animals, the FDA banned the product for over-the-counter sale in 2020.[12]
In terms of short-term effects, hydroquinone may cause a series of irritative and allergic reactions, such as dermatitis. This inflammation may lead to an altered balance of melanin deposition in the skin, causing hypo- or hyperpigmented areas in the skin (in other words, a post inflammatory hyperpigmentation).[14]
Respiratory Tract Irritation: Hydroquinone may be harmful if inhaled, causing irritation of the nose, throat and upper respiratory tract. A study on occupational exposure of hydroquinone showed that subjects exposed to hydroquinone had a higher prevalence of a cough and decreased lung capacity compared to their unexposed counterparts.[18]
[6] Choudat, D., Neukirch, F., Brochard, P., Barrat, G., Marsac, J., Conso, F., & Philbert, M. (1988). Allergy and occupational exposure to hydroquinone and to methionine. British journal of industrial medicine, 45(6), 376-380.
[14] Nordlund, J., Grimes, P. and Ortonne, J. (2006), The safety of hydroquinone. Journal of the European Academy of Dermatology and Venereology, 20: 781-787. -3083.2006.01670.x 6. Accessed April 26, 2022.
[18] Choudat, D., Neukirch, F., Brochard, P., Barrat, G., Marsac, J., Conso, F., & Philbert, M. (1988). Allergy and occupational exposure to hydroquinone and to methionine. British journal of industrial medicine, 45(6), 376-380.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Precautions Before using hydroquinone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Hydroquinone, marketed in products such as Obagi, is a medication used in skin bleaching. Hydroquinone belongs to a class of medications known as melanin synthesis inhibitors. It is thought that hydroquinone leads to a form of skin depigmentation which can be reversed by blocking enzymatic and other metabolic processes in skin cells. Hydroquinone is sometimes prescribed as a cosmetic treatment to bleach freckles, melasma, acne scars, and other areas of hyperpigmentation on the skin. The effects of hydroquinone are generally reversible when the bleached areas are exposed to ultraviolet light or sunlight. Hydroquinone is combined with fluocinolone acetonide (Synalar) and tretinoin to form Tri-Luma cream.
Hydroquinone is sometimes prescribed to be administered as a thin application once daily for three months as ultimately determined by the judgment of the medical provider. Hydroquinone itself darkens when exposed to air but is otherwise found as fine white needles. Hydroquinone 4% cream costs under $40 for 1 tube with 28 grams of cream. Hydroquinone coupons are also available online to help reduce the cost. Some insurance plans may cover costs associated with a hydroquinone ointment prescription but it depends on the insurance.
Some versions of hydroquinone are available as hydroquinone OTC (over the counter). However, prescription versions of hydroquinone are not available over the counter. For prescription hydroquinone, while many people want to just buy hydroquinone online, the first step is getting a consultation with a medical provider. Push Health can connect people interested in using hydroquinone with a medical provider who can prescribe hydroquinone medication, including hydroquinone 4% cream, when appropriate to do so.
Hydroquinone prescription medication can cause side effects when used. Side effects related to hydroquinone use include skin irritation, dryness, redness and itching. Long term use of hydroquinone can result in blue-black discoloration and the formation of small lesions on the skin. Anyone who has a hypersensitivity or allergy to hydroquinone 4% cream should not use hydroquinone ointment. Sun exposure should be closely monitored while using hydroquinone. Hydroquinone cream and alcohol should not be used at the same time. Prior to use, questions about hydroquinone and possible side effects should be discussed with a licensed medical provider and pharmacist.
Before you start using hydroquinone topical, use a "test dose" to see if you have an allergic reaction to this medicine. Apply a very small amount of the medicine to a small area of healthy skin, and check the area within 24 hours. If there is no reaction other than minor redness, begin using the full prescribed amount of the medicine.
An overdose of hydroquinone topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.
Avoid exposure to sunlight or tanning beds. Hydroquinone topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Some hydroquinone products may contain sunscreen. Check the medicine label or ask your doctor to be sure.
FCC, JECFA and EU: Tertiary Butylhydroquinone conforms with FCC, JECFA and EU specifications. Genetically Modified Organisms: Tertiary Butylhydroquinone is not produced from ingredients or processing aids derived by genetic modification. Tertiary Butylhydroquinone does not contain any genetically modified organisms.BSE/TSE: No animal derived ingredients whatsoever are used in the production of Tertiary Butylhydroquinone. Further there is no animal derived ingredient used in the facility where Tertiary Butylhydroquinone is produced.ISO CERTIFICATION: Tertiary Butylhydroquinone is ISO 9001:2008 and ISO 22000:2005 Certified.KOSHER: Tertiary Butylhydroquinone is Kosher & Pareve and can be used in Kosher food industry, pharmaceuticals & other Kosher products.HALAL: Tertiary Butylhydroquinone is Halal certified. 781b155fdc