Reversion acne controlspot treatment pm liquid

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.

Otc - when using section

Otc - keep out of reach of children section

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

Ingredients and appearance - Product information

Reversion acne controlspot treatment pm liquid- Benzoyl peroxide

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Benzoyl peroxide ( UNII: W9WZN9A0GM)( Benzoyl peroxide - UNII: W9WZN9A0GM ) 7.5 mLin 100 mL

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part333D USA

Labeler - Therapon Skin Health, LP( 792518995)

Establishment

Name ID/FEI Business Operations
Therapon Skin Health, LP 792518995 manufacture( 66428-006)

Principal display panel - 15 ml bottle label

re:version ACNE CONTROL

Spot Treatment PM