CLARIFAST ONE STEP ACNE TREATMENT- salicylic acid cream 
VIREO SYSTEMS, INC.

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CLARIFAST One Step Acne Treatment

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:

Label2

CLARIFAST ONE STEP ACNE TREATMENT 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82908-358
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82908-358-0081.33 mL in 1 JAR; Type 0: Not a Combination Product08/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00608/08/2022
Labeler - VIREO SYSTEMS, INC. (832940295)

Revised: 11/2023
Document Id: 09e37389-88df-6f4c-e063-6394a90a9861
Set id: b20a0f00-4bf2-4583-b399-7097542fff90
Version: 2
Effective Time: 20231111
 
VIREO SYSTEMS, INC.