ACNE CALMING WATER CREAM- salicylic acid cream

Acne Calming Water Cream by

Drug Labeling and Warnings

Acne Calming Water Cream by is a Otc medication manufactured, distributed, or labeled by J.A. COSMETICS U.S. INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Salicylic Acid 1%

Purpose

Acne Treatment

Uses

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

Warnings

For external use only.

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Cleanse the skin thoroughly before applying medication. 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. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated eleswhere on this label.

Inactive ingredients

Water (Aqua), Niacinamide, Glycerin, Silica, Propanediol, Isododecane, Tranexamic Acid, Glyceryl Stearate Citrate, C12-15 Alkyl Benzoate, Acetyl Glucosamine, Tromethamine, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Cetearyl Alcohol, Capryloyl Glycine, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Tocopherol, Helianthus Annuus (Sunflowe) Seed Oil, Disodium EDTA, Caprylic Acid, Sodium Citrate May Contain: Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77492)

Questions or comments

1-888-315-9814

Package Labeling:50ml

Package Labeling:30ml

INGREDIENTS AND APPEARANCE

ACNE CALMING WATER CREAM 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-416
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPANEDIOL (UNII: 5965N8W85T)
ISODODECANE (UNII: A8289P68Y2)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
TROMETHAMINE (UNII: 023C2WHX2V)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALLANTOIN (UNII: 344S277G0Z)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CAPRYLIC ACID (UNII: OBL58JN025)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-416-01	1 in 1 CARTON	02/25/2022
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 76354-416-02	1 in 1 CARTON	02/25/2022
2		30 mL 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	02/25/2022

Labeler - e.l.f. Cosmetics, Inc. (093902816)