ACNE TREATMENT DAYTIME- salicylic acid cream

Acne treatment daytime by

Drug Labeling and Warnings

Acne treatment daytime by is a Otc medication manufactured, distributed, or labeled by Malin and Goetz Inc, Milbar Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient       Purpose

Salicylic Acid (2%)    Acne Treatment

PURPOSE

Uses

for the treatment of acne

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

Warnings For external use only

DOSAGE & ADMINISTRATION

Directions

• Cleanse face thoroughly before applying

• apply directly on acne pimples

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

(Malin+Goetz)

acne treatment daytime

0.5fl. oz. 15 ml

INGREDIENTS AND APPEARANCE

ACNE TREATMENT DAYTIME 
salicylic acid cream

Product 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)