Label: ACNE WASH- salicylic acid solution
- NDC Code(s): 63550-119-17
- Packager: Kamins Dermatologics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 1, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Dosage
- Indications
- Keep out of reach of children
- Purpose
-
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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACNE WASH
salicylic acid solutionProduct 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)
