Label: GLOSSIER SOLUTION EXFOLIATING SKIN PERFECTOR liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 71425-020-13 - Packager: Glossier Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 31, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
When using this product
• avoid contact with the eyes
• if contact occurs, rinse thoroughly with water
• skin irritation and dryness are more likely to occur when
using another topical acne product at the same time. If irritation
occurs, use only one product at a time
Stop use and ask a doctor
• if you develop severe irritation, burning, or itching of the skin
• for more severe cases, and/or if improvement is not
apparent within 6-8 weeks, consult a health care professional
• if you develop hives, swelling of eyes and mouth, blistering,
or dif culty breathing, get medical help right awaySunburn 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, wearprotective clothing, and limit sun exposure while using this
product and for a week afterwards. - Keep out of reach of children
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Directions
• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three
times daily
• because excessive drying of the skin may occur, start with
one application daily, then gradually increase to two or three
times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application
to once a day or every other day -
Inactive Ingredients
Aqua/Water/Eau, Sodium Hydroxide, Lactic Acid, Glycolic
Acid, Gluconolactone, Propanediol, Ethoxydiglycol, Magnesium
Chloride, Glycereth-7 Trimethyl Ether, Niacinamide, Betaine,
Inositol, Citric Acid, Glycerin, Phytic Acid, Pentylene
Glycol, PEG-60 Hydrogenated Castor Oil, Caprylyl Glycol,
Ethylhexylglycerin, Parfum/Fragrance, PEG-8, Aloe Barbadensis
Leaf Juice, Acetic Acid, Potassium Hydroxide. - Other Information
- Questions or comments?
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INGREDIENTS AND APPEARANCE
GLOSSIER SOLUTION EXFOLIATING SKIN PERFECTOR
glossier solution exfoliating skin perfector liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71425-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM HYDRIDE (UNII: 23J3BHR95O) LACTIC ACID (UNII: 33X04XA5AT) GLYCOLIC ACID (UNII: 0WT12SX38S) GLUCONOLACTONE (UNII: WQ29KQ9POT) PROPANEDIOL (UNII: 5965N8W85T) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) GLYCERETH-7 TRIMETHYL ETHER (UNII: XMC7402M60) NIACINAMIDE (UNII: 25X51I8RD4) BETAINE (UNII: 3SCV180C9W) INOSITOL (UNII: 4L6452S749) PENTYLENE GLYCOL (UNII: 50C1307PZG) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ACETIC ACID (UNII: Q40Q9N063P) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71425-020-13 1 in 1 CARTON 11/30/2017 1 130 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 11/30/2017 Labeler - Glossier Inc. (078541007) Registrant - Glossier Inc. (078541007) Establishment Name Address ID/FEI Business Operations Thibiant International, Inc. 083913913 manufacture(71425-020)