Label: SALICYLIC SERUM 1 PERCENT- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73110-101-11 - Packager: SkinClinical AI, LLC
- 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 May 3, 2019
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- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- OTHER INFORMATION
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
Important to use on a clean face. Cover affected area with a thin layer 1 to 3 times per day. Due to excessive drying of the skin may occur, start with 1 application per day then gradually increase to 2 applications per day, one morning and one evening if needed, or as directed by a doctor. If dryness or peeling occurs, reduce use to once a day or once every other day. If going outside, use a sunscreen. If irritation or sensitivity develops stop using both products and ask a doctor.
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INACTIVE INGREDIENTS
Water (Aqua), SD Alcohol 40-B, Butylene Glycol, Ethoxydiglycol, Hamamelis Virginiana (Witch Hazel) Water, Saccharide lsomerate, Sodium Lactate, Hydrolyzed Algin, Zinc Sulfate, Glycolic Acid, Lactic Acid, Hydroxyethylcellulose, Potassium Hydroxide, Magnesium Aluminum Silicate, Citric Acid, Xanthan Gum, Fragrance (Parfum)
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INGREDIENTS AND APPEARANCE
SALICYLIC SERUM 1 PERCENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73110-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) SACCHARIDE ISOMERATE (UNII: W8K377W98I) SODIUM LACTATE (UNII: TU7HW0W0QT) SODIUM ALGINATE (UNII: C269C4G2ZQ) ZINC SULFATE (UNII: 89DS0H96TB) LACTIC ACID (UNII: 33X04XA5AT) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) XANTHAN GUM (UNII: TTV12P4NEE) GLYCOLIC ACID (UNII: 0WT12SX38S) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) WITCH HAZEL (UNII: 101I4J0U34) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73110-101-11 30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 05/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 05/10/2019 Labeler - SkinClinical AI, LLC (116981342) Registrant - SkinClinical AI, LLC (116981342)
