ACNE MOISTURIZER- salycilic acid cream

ACNE Moisturizer by

Drug Labeling and Warnings

ACNE Moisturizer by is a Otc medication manufactured, distributed, or labeled by MONAT GLOBAL CORP, COSMAX USA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT:

Salicylic Acid 2.00%

Purpose

Purpose

Acne Treatment

USES

Uses

• For the treatment of acne
• Helps prevent new acne blemishes from forming

Warnings

Warnings

For external use only

When using this product

When using this product

• skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time.
• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and consult

Stop use and consult with a doctor if irritation becomes severe

Keep out of reach of children

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center immediately.

DIRECTIONS

Directions

• Clean skin thoroughly before applying this product
• Apply a dime-sized amount onto fingers. Gently use fingertips to apply to clean and dry face using circular motions
• 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 by a doctor
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Inactive Ingredients: Water, Dimethyl Isosorbide, Glycerin, Sodium Hydroxide, Cetearyl Olivate, Caprylic/Capric Triglyceride, Lactococcus Ferment Lysate, Niacinamide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sorbitan Isostearate, Polysorbate 60, Polyacrylate Crosspolymer-6, Sorbitan Olivate, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Acacia Decurrens Flower Wax, Polyglycerin-3, Tocopherol, Coco-Caprylate/Caprate, Triheptanoin, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Physalis Angulata Extract, Lactic Acid, Sodium Hyaluronate, 1,2-Hexanediol, Polylysine, Camellia Sinensis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Bisabolol, Pentylene Glycol, Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Sodium Chloride, t-Butyl Alcohol, Chlorphenesin, Phenylpropanol, Levulinic Acid, Sodium Levulinate

Questions or comments

Questions or comments?

Toll-free number 1-800-878-1978

Primary Package

Primary Package

Secondary Package

Secondary Package

INGREDIENTS AND APPEARANCE

ACNE MOISTURIZER 
salycilic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78518-012
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 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
LEVULINIC ACID (UNII: RYX5QG61EI)
POLY-L-LYSINE (30000-70000 MW) (UNII: 0A1V8JTU2M)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENYLPROPANOL (UNII: 0F897O3O4M)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
LACTIC ACID (UNII: 33X04XA5AT)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
SORBITAN OLIVATE (UNII: MDL271E3GR)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
LACTOCOCCUS LACTIS (UNII: F1A0PSN10V)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78518-012-01	1 in 1 CARTON	04/04/2023
1		50 mg in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	04/04/2023

Labeler - MONAT GLOBAL CORP (027036949)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, INC		010990210	manufacture(78518-012)