Salicylic Acid by Acne Free, LLC / Paklab SALICYLIC ACID cream

Salicylic Acid by

Drug Labeling and Warnings

Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by Acne Free, LLC, Paklab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Use

Use for the treatment of acne

Warnings

For external use only

When using this product

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Avoid contact with eyes

Avoid contact with the eyes. It contact occurs, ush thoroughly with water.

Directions

wet hands and face squeeze scrub into hands and rub together apply to face and massage gently, avoiding contact with eyes. If contact occurs, rinse thoroughly with water. rinse face

Inactive Ingredients

water, cocamidopropyl betaine, sodium cocoyl isethionate, glycerin, coco-glucoside, hydrogenated castor oil, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, sodium benzoate, avena sativa (oat) kernel oil, guar hydroypropyltrimonium chloride, hydrogenated jojoba oil, zingiber of cinale (ginger) root juice, charcoal powder, iron oxides (CI 77499)

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SALICYLIC ACID 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80861-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80861-117-01	1 g in 1 TUBE; Type 0: Not a Combination Product	02/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	02/05/2024

Labeler - Acne Free, LLC (122237140)

Establishment
Name	Address	ID/FEI	Business Operations
Paklab		177711082	manufacture(80861-117)