CLEAR SKIN ACNE TREATMENT- salicylic acid lotion

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT:

SALICYLIC ACID 2% W/W

PURPOSE

PURPOSE:

ACNE medication

INDICATIONS & USAGE

• for the treatment of acne
• dries up acne pimples
• helps prevent new acne pimples

WARNINGS

For external use only.

When using this product

• avoid contact with eyes.If product gets into the eyes rinse thoroughly with water
• 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
• limit use to the face and neck

STOP USE

Stop use and see a doctor If skin and eye irritation develops.

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.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:

PURIFIED WATER, CETEARYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ALCOHOL, PROPYLENE GLYCOL, CETETH-20 PHOSPHATE, DICETYL PHOSPHATE, PHENOXYETHANOL, C20-40 PARETH-10, TROPOLONE, SODIUM HYDROXIDE.

DOSAGE & ADMINISTRATION

• clean the skin thoroughly before applying this product
• 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 neede or as directed by a doctor
• If bothersome dryness or peeling occurs,reduce application to once a day or every other day.

PRINCIPAL DISPLAY PANEL

MM10

INGREDIENTS AND APPEARANCE

CLEAR SKIN ACNE TREATMENT  
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64990-610
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
Water (UNII: 059QF0KO0R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetyl Alcohol (UNII: 936JST6JCN)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Propylene Glycol (UNII: 6DC9Q167V3)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Hydroxide (UNII: 55X04QC32I)
Dihexadecyl Phosphate (UNII: 2V6E5WN99N)
C20-40 Pareth-10 (UNII: TE3MZI4V3F)
Tropolone (UNII: 7L6DL16P1T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64990-610-10	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/27/2012

Labeler - Isomers Laboratories Inc. (253306799)

Registrant - Isomers Laboratories Inc. (253306799)

Establishment
Name	Address	ID/FEI	Business Operations
Isomers Laboratories Inc.		253306799	manufacture(64990-610)