CLARIFAST ONE STEP ACNE TREATMENT- salicylic acid cream

CLARIFAST One Step Acne Treatment by

Drug Labeling and Warnings

CLARIFAST One Step Acne Treatment by is a Otc medication manufactured, distributed, or labeled by VIREO SYSTEMS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Salicylic Acid 0.5 %

Purpose

Acne Treatment

Uses:

For the treatment of acne. Helps clear acne blemishes, pimples, and blackheads. Penetrates pores to reduce the number of acne blemishes, pimples and blackheads. Helps prevent new acne blemishes, pimples, and blackheads from forming. Helps prevent the development of new acne blemishes, pimples and blackheads.

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.

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

Apply to affected area and rub in lightly, one to two times daily (before bedtime or anytime during the day as desired). Allow 30 minutes to dry If drying of the skin occurs, reduce application to once a day, every other day, or as directed by a doctor.

Other information:

Protect the product in this container from excessive heat and direct sun. Store at a controlled room temperature 20-25C (68-77F).

Inactive ingredients:

Alpha-GEE®, Aloe Barbadensis Leaf Extract, Amezol®, Bellis Perennis Flower Extract, Cetyl Alcohol, Coconut Oil, Colloidal Oatmeal,  Denatured  Alcohol, Glyceryl Monostearate, Hamamelis Virginiana Extract 3X, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Polyethylene Glycol 400, Polyethylene Glycol 3350, Potassium Phosphate Dibasic, Propylene Glycol, Sulfur 1X, Zinc Oxide.

Package Labeling:

INGREDIENTS AND APPEARANCE

CLARIFAST ONE STEP ACNE TREATMENT 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82908-358
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCONUT OIL (UNII: Q9L0O73W7L)
OATMEAL (UNII: 8PI54V663Y)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TEA TREE OIL (UNII: VIF565UC2G)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82908-358-00	81.33 mL in 1 JAR; Type 0: Not a Combination Product	08/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/08/2022

Labeler - VIREO SYSTEMS, INC. (832940295)