Label: ACNE TONER SERUM- salicylic acid cream
- NDC Code(s): 82870-003-01
- Packager: Dime Beauty Co, 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 August 8, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions:
- Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.
- 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.
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Butylene Glycol, Propanediol, Pentylene Glycol, 1,2-Hexanediol, Sodium Polyacryloyldimethyl Taurate Octyldodecanol, Glycerin, Hydroxyacetophenone, Pyrus Malus (Apple) Fruit Extract, Sodium Hydroxide, Beta Vulgaris (Beet) Root Extract, Fructooligosaccharides, Hydroxyethylcellulose, Tetrahexyldecyl Ascorbate, Tetrasodium Glutamate Diacetate, Leptospermum Scoparium Branch/Leaf Oil, Aloe Barbadensis Leaf Juice, Magnolia Officinalis Bark Extract, Piper Nigrum (Pepper) Seed Extract, Phragmites Communis Extract, Poria Cocos Extract
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE TONER SERUM
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82870-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength PENTYLENE GLYCOL (UNII: 50C1307PZG) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) GLYCERIN (UNII: PDC6A3C0OX) APPLE (UNII: B423VGH5S9) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) PROPANEDIOL (UNII: 5965N8W85T) BEET (UNII: N487KM8COK) WATER (UNII: 059QF0KO0R) FU LING (UNII: XH37TWY5O4) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) MANUKA OIL (UNII: M6QU9ZUH2X) ALOE VERA LEAF (UNII: ZY81Z83H0X) WHITE PEPPER (UNII: M29DW54Q9E) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82870-003-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/12/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 08/12/2022 Labeler - Dime Beauty Co, LLC (058459261)
