Label: ACNE DEFENSE SPOT TREATMENT MERLE NORMAN- salicylic acid gel
- NDC Code(s): 57627-201-01, 57627-201-02
- Packager: Merle Norman Cosmetics, 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 January 27, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
SD Alcohol 40-B, Aqua/Water/Eau, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Polyacrylate Crosspolymer 6, Laminaria Saccarina Extract, Thermus Thermophillus Ferment, Opuntia Ficus-Indica Stem Extract, Sea Whip Extract, Bisabolol, Glycerin, Pentylene Glycol, Butylene Glycol, Propylene Glycol, Aminomethyl Propanol, 4-t-Butylcyclohexanol, Hydroxyethylcellulose, Hydroxymethoxyphenyl Decanone, Benzalkonium Chloride
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE DEFENSE SPOT TREATMENT MERLE NORMAN
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57627-201 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 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) THERMUS THERMOPHILUS LYSATE (UNII: 775R692494) OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) LEVOMENOL (UNII: 24WE03BX2T) GLYCERIN (UNII: PDC6A3C0OX) PENTYLENE GLYCOL (UNII: 50C1307PZG) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) 1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57627-201-02 1 in 1 CARTON 07/14/2017 1 NDC:57627-201-01 14 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 07/14/2017 Labeler - Merle Norman Cosmetics, Inc (008479388) Registrant - Merle Norman Cosmetics, Inc (008479388) Establishment Name Address ID/FEI Business Operations Merle Norman Cosmetics, Inc 008479388 manufacture(57627-201)