CARADERMA- benzoyl peroxide cream

CaraDerma by

Drug Labeling and Warnings

CaraDerma by is a Otc medication manufactured, distributed, or labeled by A Refreshing Discovery, Inc., Advanced Skin Technologies Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CARADERMA 
benzoyl peroxide cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	1.125 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENTONITE (UNII: A3N5ZCN45C)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROCORTISONE (UNII: WI4X0X7BPJ)
PHENACETIN (UNII: ER0CTH01H9)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51130-333-12	1 in 1 CARTON
1		15 g in 1 JAR

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	Business Operations
Advanced Skin Technologies Inc.		176084556	MANUFACTURE