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NDC 75834-0137-01 Hydroquinone 4% 40 mg/g Details
Hydroquinone 4% 40 mg/g
Hydroquinone 4% is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Nivagen Pharmaceuticals, Inc.. The primary component is HYDROQUINONE.
Product Information
| NDC | 75834-0137 |
|---|---|
| Product ID | 75834-137_7844c308-e0a2-42e7-bd28-f68a59ebca83 |
| Associated GPIs | |
| GCN Sequence Number | 006313 |
| GCN Sequence Number Description | hydroquinone CREAM (G) 4 % TOPICAL |
| HIC3 | L9C |
| HIC3 Description | HYPOPIGMENTATION AGENTS |
| GCN | 24883 |
| HICL Sequence Number | 002721 |
| HICL Sequence Number Description | HYDROQUINONE |
| Brand/Generic | Generic |
| Proprietary Name | Hydroquinone 4% |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydroquinone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/g |
| Substance Name | HYDROQUINONE |
| Labeler Name | Nivagen Pharmaceuticals, Inc. |
| Pharmaceutical Class | Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 75834-0137-01 (75834013701)
| NDC Package Code | 75834-137-01 |
|---|---|
| Billing NDC | 75834013701 |
| Package | 1 TUBE in 1 CARTON (75834-137-01) / 28.4 g in 1 TUBE |
| Marketing Start Date | 2022-08-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7844c308-e0a2-42e7-bd28-f68a59ebca83 Details
DESCRIPTION
Each gram of Hydroquinone USP, 4% Skin Bleaching Cream contains 40 mg of hydroquinone USP, in a vanishing cream base of aqua (water), BHT, cetyl alcohol, disodium EDTA, glycerin, glycolic acid, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, tetrahexyldecyl ascorbate, and tocopheryl acetate. Chemically, hydroquinone is C6H6O2 and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is:
CLINICAL PHARMACOLOGY
Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (dopa) (Denton, C. et al., 1952)1 and suppression of other melanocyte metabolic processes (Jimbow, K. et al., 1974)2. Exposure to sunlight or ultraviolet light will cause repigmentation of bleached areas (Parrish, J.A. et al., 1978)3.
INDICATIONS & USAGE
CONTRAINDICATIONS
WARNINGS
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Since this product contains no sunscreen, an effective broad spectrum sun blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring. Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician. The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.
PRECAUTIONS
(see WARNINGS)
GENERAL PRECAUTIONS
Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response further treatment is not advised. Close patient supervision is recommended.
Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.
INFORMATION FOR PATIENTS
Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. To prevent repigmentation, during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) or by use of protective clothing.
Avoid contact with eyes and mucous membranes.
Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.
DRUG INTERACTIONS
Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.
Published studies have demonstrated that hydroquinone is a mutagen and a clastogen. Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay.
PREGNANCY
Teratogenic Effects: Pregnancy Category C -
Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.
ADVERSE REACTIONS
The following adverse reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging.
Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued and the physician notified immediately.
OVERDOSAGE
DOSAGE & ADMINISTRATION
Hydroquinone USP, 4% Skin Bleaching Cream should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. If no improvement is seen after 2 months of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.
HOW SUPPLIED
Hydroquinone USP, 4% Skin Bleaching Cream is available as follows:
1 oz (28.4 g) tube (NDC 75834-137-01)
STORAGE
Hydroquinone USP, 4% Skin Bleaching Cream should be stored at controlled room temperature (20-25°C) (68-77°F). Darkening of this product is normal.
This will not affect performance or safety.
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein.
REFERENCES
1 DENTON C., LERNER A.B., FITZPATRICKT.B.
Inhibition of Melanin Formation by Chemical Agents
Journal of Investigative Dermatology 1952, 18:119-135.
2 JIMBOW K., OBATA H., PATHAK M., FITZPATRICK T.B.
Mechanism of Depigmentation by Hydroquinone
Journal of Investigative Dermatology 1974, 62:436-449.
3 PARRISH J.A., ANDERSON R.R., URBACH F., PITTS D.
UVA, Biological Effects of Ultraviolet Radiation with Emphasis on Human Responses to Longwave Ultraviolet
Plenum Press, New York and London, 1978, p. 151.
Manufactured for:
Nivagen Pharmaceuticals, Inc.
Sacramento, CA 95827 USA
Toll free number: 1-877-977-0687
Rev. 02/2022
Hydroquinone USP, 4%
Skin Bleaching Cream
INGREDIENTS AND APPEARANCE
| HYDROQUINONE 4%
hydroquinone cream |
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| Labeler - Nivagen Pharmaceuticals, Inc. (052032418) |