REVERSION ACNE CONTROL SPOT TREATMENT PM- benzoyl peroxide 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

Benzoyl Peroxide 7.5%

Purpose

Acne treatment

Uses

• 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.
• Do not use if you.
• have very sensitive skin.
• are sensitive to benzoyl peroxide.
• When using this product.
• avoide unnecessary sun exposure and use a sunscreen.
• avoid contact with dyed fabrics, which may be bleached by this product.
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequentl or in a lower concentration.
• Stop use and ask a doctor if irritation becomes severe.
• Keep out of reach of children.
• If swallowed, get medical help or contact poison control.

Directions

• Cleanse the skin thoroughly before applying medication.
• Cover blemish and surrounding area with a thin layer of medication before bed.
• In the morning, wash and pat dry.
• Contnue using until blemish has disappeared
• If bothersome dryness or peeling occurs, reduce application to every other day.
• If going outside, apply a broad-spectrum sunscreen after using this product.
• If irritation or sensitivity develops, stop use of product and ask a doctor.

Inactive ingredients

Aloe barbadensis leaf juice, Bentonite, Kaolin, Glycerin, Propylene glycol, Cetyl alcohol, Glyceryl stearate, PEG-100 stearate, Triticum vulgare (wheat) germ oil, Zinc oxide, Titanium dioxide, Phenoxyethanol, Simmondsia chinensis (jojoba) seed oil, Magnesium aluminum silicate, Chamomilla recutita (matricaria) flower extract, Eucalyptus globulus leaf oil, Methylisothiazolinone

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 - 15 ml Bottle Label

re:version ACNE CONTROL

Spot Treatment PM

INGREDIENTS AND APPEARANCE

REVERSION ACNE CONTROL  SPOT TREATMENT PM
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66428-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	7.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENTONITE (UNII: A3N5ZCN45C)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
WHEAT GERM (UNII: YR3G369F5A)
ZINC OXIDE (UNII: SOI2LOH54Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CHAMOMILE (UNII: FGL3685T2X)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66428-006-01	15 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(66428-006)