ACNE WASH- salicylic acid solution

Acne Wash by

Drug Labeling and Warnings

Acne Wash by is a Otc medication manufactured, distributed, or labeled by Kamins Dermatologics, Odan Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage

apply to wet face, gently massage with fingertips and rinse thoroughly. Use once daily, increasing up to 2-3 times daily.

Indications

Salicylic acid 2%

medicated solution for acne

A gentle effective cleanser with lactic,

glycolic and salicylic acids to help

control acne breakouts without

overdrying the skin

Keep out of reach of children

Keep out of reach of children. If swallowed seek medical assisstance or contact a Poison Control Center immediately.

Purpose

A gentle skin cleanser that effectively helps to control acne breakouts. Contains moisturizing Bio-MapleTM compound, which prevents skin from overdrying.

Warnings

For external only:

When using this product

■ avoid contact with eyes; if contact occurs,

rinse thoroughly with water.

■ If excessive skin irritation develops or

increases, discontinue use; if irritation

persists, consult a health care

professional.

■ it is recommended that prior to exposure

to the sun, users cover with sunscreen

areas to which AHAs have been applied

(i.e. glycolic acid, lactic acid) and for one

week afterwards.

■ using other topical acne products 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

health care professional.

Active ingredient

Active ingredient: Salicylic Acid

Inactive ingredients

Inactive ingredients:

aqua/water/eau, lauryl glucoside, PEG-120 methyl glucosedioleate, acer saccharum (maple isolate /isolat d’érable), glycerin, PEG-7 glycerylcocoate, glycolic acid, lactic acid, sodiumhydroxide, panthenol, allantoin, menthapiperita (peppermint) oil.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE WASH 
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63550-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)	200 mg  in 1 mL
PANTHENOL (UNII: WV9CM0O67Z)	1.3 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)	9.4 mg  in 1 mL
ALLANTOIN (UNII: 344S277G0Z)	1 mg  in 1 mL
PEPPERMINT OIL (UNII: AV092KU4JH)	1 mg  in 1 mL
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)	30 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX)	30 mg  in 1 mL
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)	30 mg  in 1 mL
GLYCOLIC ACID (UNII: 0WT12SX38S)	7.5 mg  in 1 mL
LACTIC ACID (UNII: 33X04XA5AT)	10 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	587.3 mg  in 1 mL
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)	50 mg  in 1 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63550-119-17	180 mL in 1 BOTTLE; Type 6: Drug/Biologic Combination	10/01/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358B	10/01/2004

Labeler - Kamins Dermatologics (254050784)

Establishment
Name	Address	ID/FEI	Business Operations
Odan Laboratories		208585604	manufacture(63550-119)