REVERSION ACNE CONTROL CLARIFYING CLEANSER- salicylic acid liquid

Reversion Acne Control by

Drug Labeling and Warnings

Reversion Acne Control by is a Otc medication manufactured, distributed, or labeled by Therapon Skin Health, LP, Chemolee Lab Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 1.0 %

Purpose

Acne treatment

Indications

• For the treatment of acne.
• Reduces the number of acne blemishes.
• Helps prevents new blemishes from forming.

Warnings

• For external use only.
• Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
• Keep out of reach of children.
• If swallowed, get medical help or contact poison control.

Directions

• Apply a dime-sized amount to damp skin.
• Massage gently over skin, avoiding eye area.
• Rinse thoroughly with warm water.
• Pat Dry.
• Use AM and PM.
• If bothersome drying or peeling occurs, reduce application to once a day or every other day.
• After acne clears, continue using for preventative care

Inactive ingredients

Water, Sodium laureth sulfate, Cocamidopropyl betaine, Cocamide DEA, Glycerin, Sorbitol, Chloroxylenol, Phenoxyethanol, Camellia oleifera (Japanese green tea) leaf extract, Sodium hydroxide, Fragrance, Methylisothiazolinone, Red 33

SPL UNCLASSIFIED SECTION

Best used within 12 months of opening.

1.800.443.7549

www.reversion.com

dist. by Therapon Skin Health
Springdale, AR 72764
Made in the USA

PRINCIPAL DISPLAY PANEL - 60 ml Bottle Label

re:version ACNE CONTROL

Clarifying Cleanser

INGREDIENTS AND APPEARANCE

REVERSION ACNE CONTROL  CLARIFYING CLEANSER
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66428-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ)	salicylic acid	1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66428-003-01	60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	09/07/2012

Labeler - Therapon Skin Health, LP (792518995)

Establishment
Name	Address	ID/FEI	Business Operations
Chemolee Lab Corporation		809982754	manufacture(66428-003)