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HYPERPIGMENTATION TREATMENT

Dosage form: lotion
Ingredients: HYDROQUINONE 2g in 100mL
Labeler: Skin Authority LLC
NDC Code: 46007-301

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.

HYPERPIGMENTATION TREATMENT

ACTIVE INGREDIENTS

HYDROQUINONE (2%)

PURPOSES

WHITENING AGENT

USES:

HELPS EXFOLIATE AND FADE SPOTS, FRECKLES, AND HYPERPIGMENTATION FOR IMPROVED CLARITY, AND BRIGHTNESS.

DO NOT USE WHILE PREGNANT OR NURSING.

DIRECTIONS:

USING FINGER TIPS, APPLY A THIN LAYER OVER TREATMENT AREAS (AVOIDING EYES AND EYE LIDS). USE BEFORE APPLYING MOISTURIZERS, SUNSCREENS, AND MAKEUP.

OTHER INGREDIENTS:

WATER, SD ALCOHOL 40, GLYCOLIC ACID, POLYQUATERNIUM-10, SODIUM SULFITE, SODIUM BISULFITE, ASCORBYL METHYLSILANOL PECTINATE, ALLANTOIN, CITRIC ACID, DISODIUM EDTA, SODIUM HYDROXIDE, BHA.

QUESTIONS? +1-760-268-0047

SKIN AUTHORITY

HYPERPIGMENTATION TREATMENT

SKIN LIGHTENER

1.7 FL OZ   50 ML


KEEP OUT OF REACH OF CHILDREN.

HYPERPIGMENTATION TREATMENT 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46007-301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
GLYCOLIC ACID 
POLYQUATERNIUM-10 (400 CPS AT 2%) 
SODIUM SULFITE 
SODIUM BISULFITE 
ASCORBYL PALMITATE 
ALLANTOIN 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
BUTYLATED HYDROXYANISOLE 
Packaging
#Item CodePackage Description
1NDC:46007-301-1250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358A04/19/2012
Labeler - Skin Authority LLC (136549396)
Registrant - Skin Authority LLC (136549396)
Establishment
NameAddressID/FEIOperations
Packaging On Demand Inc610511326manufacture

Revised: 04/2012
 
Skin Authority LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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