ACNE TREATMENT DAYTIME- salicylic acid cream 
Malin and Goetz Inc

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.

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Acne Treatment Daytime

Active ingredient       Purpose

Salicylic Acid (2%)    Acne Treatment

Uses

for the treatment of acne

Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used, unless directed by a doctor

Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should  be used, unless directed by a doctor

Warnings For external use only

Directions

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

(Malin+Goetz)

acne treatment daytime

0.5fl. oz. 15 ml

carton

tube

ACNE TREATMENT DAYTIME 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53634-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53634-125-021 in 1 CARTON01/03/2018
1NDC:53634-125-0115 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/03/2018
Labeler - Malin and Goetz Inc (138615930)
Establishment
NameAddressID/FEIBusiness Operations
Milbar Laboratories, Inc.195556790manufacture(53634-125)

Revised: 1/2021
Document Id: b9d32dc5-b983-589d-e053-2a95a90a53b4
Set id: 61ce6585-0cde-4d21-84b8-f37a95327605
Version: 4
Effective Time: 20210126
 
Malin and Goetz Inc