DUAL ACTION SKIN LIGHTENER- hydroquinone lotion 
Neoteric Cosmetics, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dual Action Skin Lightener

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 FOR NEOTERIC COSMETICS, INC., Greenwood Village, CO 80111

PRINCIPAL DISPLAY PANEL

Alpha
skin care
Dual Action
Skin Lightener
Net Wt. 0.85 oz. (24g)

PRINCIPAL DISPLAY PANEL
Alpha
skin care
Dual Action
Skin Lightener
Net Wt. 0.85 oz. (24g)

DUAL ACTION SKIN LIGHTENER 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62673-162
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE.02 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62673-162-211 in 1 CARTON05/01/200604/26/2022
124 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A05/01/200604/26/2022
Labeler - Neoteric Cosmetics, Inc. (790615181)

Revised: 9/2022
 
Neoteric Cosmetics, Inc.