Label: BALANCER- hydroquinone cream
- NDC Code(s): 68723-143-02
- Packager: Axia Medical Solutions, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated February 19, 2021
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- SPL UNCLASSIFIED SECTION
Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic hydroquinone. oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) and suppression of other melanocyte metabolic processes.
The selective inhibition of the enzyme affects melanogenesis in the melanocytes resulting in cessation of melanin formation and subsequent reduction in pigmentation. Additional studies indicate Hydroquinone acts on the essential subcellular metabolic processes of melanocytes with resultant cytolysis, i.e. nonenzymediated depigmentation.
Exposure to sunlight or ultraviolet light will cause regimentation of the bleached areas, which may be prevented by the use of sunblocking agents.
- INDICATIONS AND USAGE
- CAUTION: 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.
- Test for skin sensitivity before using Hydroquinone Cream by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching and vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended. Contact with the eyes should be avoided. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and anesthetic effect may occur if applied to lips. Keep out of reach of children. If no bleaching or lightening effect is noted after 2 months of treatment use, Hydroquinone Creamshould be discontinued. This productis formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn.
- Sunscreen use is an essential aspect of Hydroquinone therapy because even minimal sunlight sustains melanocytic activity. After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a sunscreen or sunblock agent, or protective clothing to prevent repigmentation. There are no sunblocking or sunscreening agents in DERMESSE BALANCER and since minimal sunlight exposure may reverse the bleaching effect of this preparation. It should be used only at night or on areas of the body covered by protective clothing. During the daytime, sunblocking or broad spectrum sunscreen preparations or protective clothing should be used to prevent the bleached areas from repigmentation.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- Warning: Contains sodium metabisulfite, a sulfite that may cause serious allergic type reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons.
A. Pregnancy Category C
Animal reproduction studies have not been conducted with topical Hydroquinone. It is also not known whether Hydroquinone can cause fetal harm when used topically on a pregnant woman or can affect reproductive capacity. It is not known to what degree, if any, topical Hydroquinone is absorbed systemically. Topical Hydroquinone should be used in women only when clearly indicated.
B. Nursing mothers
It is not known whether topical Hydroquinone is absorbed or excreted in human milk. Caution is advised when topical Hydroquinone is used by a nursing mother.
- ADVERSE REACTIONS
DRUG DOSAGE AND ADMINSTRATION
A thin application of DERMESSE BALANCER should be applied to the affected area twice daily or as directed by a physician. Consult product label for instructions on whether to rub in or not. There is no recommendation for children under the age of 12 years of age except under the advice and supervision of a physician.
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68723-143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone 40 mg in 1 g Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCOLIC ACID (UNII: 0WT12SX38S) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) CAULOSIDE D (UNII: 4N5Z068GAZ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM METABISULFITE (UNII: 4VON5FNS3C) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68723-143-02 1 in 1 BOX 12/01/1990 1 57 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 12/01/1990 Labeler - Axia Medical Solutions, LLC (929224694) Establishment Name Address ID/FEI Business Operations Axia Medical Solutions, LLC 929224694 manufacture(68723-143)