Skin Authority - HYPERPIGMENTATION TREATMENT (46007-301) - DELIST

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

KEEP OUT OF REACH OF CHILDREN.

HyperpigmentationTreatment_LBL_50ml

HYPERPIGMENTATION TREATMENT
hydroquinone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46007-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCOLIC ACID (UNII: 0WT12SX38S)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
SODIUM SULFITE (UNII: VTK01UQK3G)
SODIUM BISULFITE (UNII: TZX5469Z6I)
ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)
ALLANTOIN (UNII: 344S277G0Z)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46007-301-12	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2012	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	04/19/2012	12/31/2021

Labeler - Skin Authority LLC (136549396)

Revised: 10/2023

Document Id: 06fe55f3-5663-1955-e063-6394a90a1291

Set id: c561a16f-a8a1-464b-8b64-5c4c2bcd1886

Version: 7

Effective Time: 20231005

Skin Authority LLC