- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
• Adults: apply a thin layer on the affected areas twice daily, or as directed by a doctor
• If no improvement is seen after 3 months of treatment, use of this product should be discontinued
• Lightening effect of this product may not be noticeable when used on very dark skin
• Children under 12 years of age: do not use this product unless directed by a doctor. Sun exposure should be limited by using a sunscreen agent, sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
Sunburn Alert
• This product contains an Alpha Hydroxy Acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
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Inactive Ingredients
Water, Glycolic Acid, Propylene Glycol, Isopropyl Palmitate, Mineral Oil, Glyceryl Stearate, Cetyl Alcohol, Ozokerite, Sodium Hydroxide, Steareth-20, Laureth-23, Tocopherol (Vitamin E), Dimethicone, Xanthan Gum, Sodium PVM/MA Decadiene Crosspolymer, Sorbic Acid, Sodium Metabisulfite, Imidazolidinyl Urea, Tetrasodium EDTA, Fragrance, BHT
MANUFACTURED FOR NEOTERIC COSMETICS, INC., Greenwood Village, CO 80111
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DUAL ACTION SKIN LIGHTENER
hydroquinone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62673-162 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE .02 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCOLIC ACID (UNII: 0WT12SX38S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) MINERAL OIL (UNII: T5L8T28FGP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) CERESIN (UNII: Q1LS2UJO3A) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARETH-20 (UNII: L0Q8IK9E08) LAURETH-23 (UNII: N72LMW566G) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHICONE (UNII: 92RU3N3Y1O) XANTHAN GUM (UNII: TTV12P4NEE) SORBIC ACID (UNII: X045WJ989B) SODIUM METABISULFITE (UNII: 4VON5FNS3C) IMIDUREA (UNII: M629807ATL) EDETATE SODIUM (UNII: MP1J8420LU) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62673-162-21 1 in 1 CARTON 05/01/2006 1 24 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part358A 05/01/2006 Labeler - Neoteric Cosmetics, Inc. (790615181)