Active ingredient

Benzoyl Peroxide 7.5%

Purpose

Acne Treatment

Use

for the management of acne

Warnings

For external use only

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Ask a doctor before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

When using this product

Do not use in or near eyes. If contact occurs, rinse thoroughly with water.
Keep away from lips and mouth.
Avoid unnecessary sun exposure and use a sunscreen.

Stop use and ask a doctor if skin irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Other information

This product may bleach hair or dyed fabrics. Store at 20-25°C (68-77°F).

Inactive ingredients

Aluminum Hydroxide, Bentonite, Carbomer Homopolymer Type C, Cetyl Alcohol, Diazolidinyl Urea, Glyceryl Monostearate, Hepes, Hydrocortisone, Isopropyl Myristate, Methylparaben, Phenacetin, Polyethylene Glycol, Propylene Glycol, Propylparaben, Sodium Benzoate, Water

Directions

Cleanse the skin thoroughly before applying.
Cover the entire affected area with a thin layer one to three times daily.
Because excessive drying 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 going outside, use a sunscreen.
Allow CaraDerma® to dry before applying sunscreen.
If irritation or sensitivity develops, discontinue use and consult a doctor.

Package/Label Principal Display Panel

CaraDerma®

OOO acne treatment

anti-inflammatory properties

works on cystic acne

fast acting

For Moderate to Severe Acne

Works on All Skin Types

Active Ingredient:

Benzoyl Peroxide 7.5%

Net Wt: 1/2 oz. (15 grams)

Manufactured for

A Refreshing Discovery, Inc.

Raleigh, NC 27614

Made in the USA

Carton Label

CARADERMA
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	51130-333
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE)	BENZOYL PEROXIDE	1.125 g in 15 g

Inactive Ingredients
Ingredient Name	Strength
WATER
GLYCERYL MONOSTEARATE
PROPYLENE GLYCOL
BENTONITE
ISOPROPYL MYRISTATE
CETYL ALCOHOL
HYDROCORTISONE
PHENACETIN
ALUMINUM HYDROXIDE
SODIUM BENZOATE
METHYLPARABEN
PROPYLPARABEN
POLYETHYLENE GLYCOL
CARBOMER HOMOPOLYMER TYPE C
DIAZOLIDINYL UREA
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	51130-333-12	1 JAR In 1 CARTON	contains a JAR
1		15 g In 1 JAR	This package is contained within the CARTON (51130-333-12)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333D	09/02/2010

Labeler - A Refreshing Discovery, Inc. (604440243)

Establishment
Name	Address	ID/FEI	Operations
Fragrance Manufacturing, Inc.		793406000	MANUFACTURE

Revised: 09/2010A Refreshing Discovery, Inc.