Label: SMART RELEASE MANDELIC 8 PERCENT- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73110-103-11 - 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 June 29, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- OTHER INFORMATION
- STOP USE
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KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poisorl fontrol Center right away. This product contains Mandelic Acid that may increase. Your skin's sensitivity to the sun and the possibility of sunburn. Use a sunscreen, wear protective clothing and limit exposure to the sun using this product and for one week after you stop. Store at room temperature.
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DIRECTIONS
Important to use on a clean face, Cover the affected area with a thin layer 1 to 3 times per day. Because of 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 ff 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 (Agua), SD Alcohol 40-B, Mandelic Acid, Butylene Glycol,Hamamelis Virginiana (Witch Hazel) Leaf Water, Lactobacillus Ferment, PEG-8 SMDI Copolymer, Niacinamide, Lactic Acid, Sodium PCA, Sodium Lactate, Hydrolyzed Algin, Zinc Sulfate, Glycerin, Opuntia Ficus lndica (Nopal Cactus), Saccharomyces Cerevisiae (Yeast) Extract, Hydroxyethylcellulose, Vaccinium Myrtillus Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oi!, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Tangerina (Tangerine) Peel Oil
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SMART RELEASE MANDELIC 8 PERCENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73110-103 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 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) MANDELIC ACID (UNII: NH496X0UJX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) WITCH HAZEL (UNII: 101I4J0U34) LACTOBACILLUS REUTERI (UNII: 9913I24QEE) PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6) NIACINAMIDE (UNII: 25X51I8RD4) LACTIC ACID (UNII: 33X04XA5AT) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SODIUM LACTATE (UNII: TU7HW0W0QT) SODIUM ALGINATE (UNII: C269C4G2ZQ) ZINC SULFATE (UNII: 89DS0H96TB) GLYCERIN (UNII: PDC6A3C0OX) OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) BILBERRY (UNII: 9P2U39H18W) SACCHARUM OFFICINARUM WHOLE (UNII: 3Z20C92XNB) ORANGE (UNII: 5EVU04N5QU) LEMON (UNII: 24RS0A988O) BERGAMOT OIL (UNII: 39W1PKE3JI) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) ORANGE OIL (UNII: AKN3KSD11B) MANDARIN OIL (UNII: NJO720F72R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73110-103-11 30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 02/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/16/2019 Labeler - SkinClinical AI, LLC (116981342) Registrant - SkinClinical AI, LLC (116981342)
