HYPERPIGMENTATION TREATMENT- hydroquinone lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)

Available from:

Skin Authority LLC

INN (International Name):

HYDROQUINONE

Composition:

HYDROQUINONE 2 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

PURPOSES WHITENING AGENT USES: HELPS EXFOLIATE AND FADE SPOTS, FRECKLES, AND HYPERPIGMENTATION FOR IMPROVED CLARITY, AND BRIGHTNESS.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HYPERPIGMENTATION TREATMENT- HYDROQUINONE LOTION
SKIN AUTHORITY LLC
_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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SKIN AUTHORITY - HYPERPIGMENTATION TREATMENT (46007-301)
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? [phone]
KEEP OUT OF REACH OF CHILDREN.
HYPERPIGMENTATION TREATMENT
hydroquinone lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:46007-301
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)
HYDROQUINONE
2 g in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
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)
Skin Authority LLC
ALLANTOIN (UNII: 344S277G0Z)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:46007-301-
12
50 mL in 1 BOTTLE; Type 0: Not a Combination
Product
04/19/2012
MARKETING INFORMATION
MARKETING
CATE