DUAL ACTION SKIN LIGHTENER- hydroquinone lotion

Dual Action Skin Lightener by

Drug Labeling and Warnings

Dual Action Skin Lightener by is a Otc medication manufactured, distributed, or labeled by Neoteric Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Dual Action Skin Lightener

Drug Facts

Active Ingredients

Hydroquinone 2%

Purpose

Skin Lightener

Uses

Lightens dark spots in the skin, such as freckles, age spots, and liver spots.

Warnings

Avoid contact with eyelids and eyes

Some users of this product may experience a mild skin irritation

If skin irritation becomes severe, stop use and consult a doctor

Do not use on children under 12 years of age, unless directed by a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

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.

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 BY NEOTERIC COSMETICS, INC., DENVER, CO 80239

PRINCIPAL DISPLAY PANEL

Alpha
skin care
Dual Action
Skin Lightener
Net Wt. 85 oz. (24g)

INGREDIENTS AND APPEARANCE

DUAL ACTION SKIN LIGHTENER 
hydroquinone lotion

Product 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)