REFORM- benzoyl peroxide cream 
SCHWEIGER DERMATOLOGY GROUP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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REFORM

Drug Facts

Active Ingredient(s)

Benzoyl Peroxide 5.25%

Purpose

Acne Treatment

Use

For the treatment of Acne.

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

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation maybe reduced by using the product less frequently or in a lower concentration

Stop use and ask a doctor if

  • irritation becomes severe

Directions

Inactive Ingredients

Aqua (Water), Glycerin, Allantoin, Aloe Barbadensis Leaf Juice Powder1, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitol, Sodium Hydroxide, Caprylyl Glycol, Phenoxyethanol


1
Certified Organic Ingredient

Questions

1 888 311 7444

Keep out of Reach of Children.

Distributed by: Schweiger Dermatology Group
New York, New York 10019

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

SKIN SOLUTIONS
dr. Schweiger
NEW YORK

Reform

Acne Fighting Cream

30 mL / 1 oz. e

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
REFORM 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70911-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE52.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
SORBITOL (UNII: 506T60A25R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70911-112-121 in 1 CARTON01/01/2017
1NDC:70911-112-1130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/01/2017
Labeler - SCHWEIGER DERMATOLOGY GROUP (007492566)

Revised: 10/2016
Document Id: 6ef35a75-9c1c-4318-9656-17bec16f68ca
Set id: faddcbe0-e7d0-4cd8-b9a8-9d044f39a9da
Version: 2
Effective Time: 20161026
 
SCHWEIGER DERMATOLOGY GROUP