Label: ACNE TREATMENT DAYTIME- salicylic acid cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 53634-125-01, 53634-125-02 - Packager: Malin and Goetz 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 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
Water (Aqua), Alcohol, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) water, Lactic Acid, Salicylic Acid, PEG-40 Hydrogenated Castor Oil, PPG-26-Buteth-26, Hydroxyethylcellulose, Sodium C8-16 Isoalkylsuccinyl Soy Sulfonate, Ammonium hydroxide, Farnesol, Fragrance (parfum), Glycerin, Tetra-sodium EDTA, Niacinamide, Panthenol, Lavandula Angustifolia (Lavender) Flower Extract, Camellia Oleifera Leaf Extract, Ascorbic Acid, Echinacea Purpurea Extract, Cymbopogon Schoenanthus Extract, Sodium Hyaluronate, Limonene, Propylene Glycol, Hexyl Cinnamal Epilobium Angustifolium Flower/Leaf/Stem Extract, Hypnea Musciformis Extract, Citronellol, Betaine, Saccharomyces Lysate Extract, Sargassum Filipendula Extract, Butylphenyl Methylpropional, Sorbitol, Saccharomyces/copper ferment, Saccharomyces/Zinc Ferment, Sodium PCA, Saccharomyces/Iron Ferment, Saccharomyces/magnesium Ferment, Glycyrrhiza (Licorice) Root Extract, Saccharomyces/Silicon Ferment, Linalool, Citral, Coumarin, Gellidiela Acerosa Extract, Tocopheryl Acetate, Yucca Schidigera Root Extract, Retinyl Palmitate, Phenoxyethanol, Cinnamomum Cassia Bark Extract, Proline, Poterium Officinale Root Extract, Zingiber Officiale (Ginger) Root Extract, Serine, Blue 1 (CI 42090), Glycine, Glutamic Acid, Lysine, Alanine, Arginine, Lecithin, Bisabolol, Threonine, Silica, Pyrus Malus (Apple) Fruit Extract,Cola Acuminata Seed Extract
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACNE TREATMENT DAYTIME
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53634-125 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 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) LACTIC ACID (UNII: 33X04XA5AT) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5) AMMONIA (UNII: 5138Q19F1X) FARNESOL (UNII: EB41QIU6JL) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) PANTHENOL (UNII: WV9CM0O67Z) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) ASCORBIC ACID (UNII: PQ6CK8PD0R) ECHINACEA PURPUREA (UNII: QI7G114Y98) CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W) HYALURONATE SODIUM (UNII: YSE9PPT4TH) LIMONENE, (+)- (UNII: GFD7C86Q1W) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) HYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV) BETAINE (UNII: 3SCV180C9W) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) SARGASSUM FILIPENDULA (UNII: 55P66J5H7N) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) SORBITOL (UNII: 506T60A25R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) LINALOOL, (+)- (UNII: F4VNO44C09) CITRAL (UNII: T7EU0O9VPP) COUMARIN (UNII: A4VZ22K1WT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHINESE CINNAMON (UNII: WS4CQ062KM) PROLINE (UNII: 9DLQ4CIU6V) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) SERINE (UNII: 452VLY9402) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCINE (UNII: TE7660XO1C) GLUTAMIC ACID (UNII: 3KX376GY7L) LYSINE (UNII: K3Z4F929H6) ALANINE (UNII: OF5P57N2ZX) ARGININE (UNII: 94ZLA3W45F) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) LEVOMENOL (UNII: 24WE03BX2T) THREONINE (UNII: 2ZD004190S) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) APPLE (UNII: B423VGH5S9) COLA ACUMINATA SEED (UNII: 1F8VIW1479) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53634-125-02 1 in 1 CARTON 01/03/2018 1 NDC:53634-125-01 15 mL in 1 PACKAGE; 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 01/03/2018 Labeler - Malin and Goetz Inc (138615930) Establishment Name Address ID/FEI Business Operations Milbar Laboratories, Inc. 195556790 manufacture(53634-125)
