REFORM- benzoyl peroxide cream

REFORM by

Drug Labeling and Warnings

REFORM by is a Otc medication manufactured, distributed, or labeled by SCHWEIGER DERMATOLOGY GROUP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer one to three times daily.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce the application to once a day or every other day.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

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

Keep out of Reach of Children.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

REFORM 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70911-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	52.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70911-112-12	1 in 1 CARTON	01/01/2017
1	NDC: 70911-112-11	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/01/2017

Labeler - SCHWEIGER DERMATOLOGY GROUP (007492566)