CARADERMA- benzoyl peroxide cream 
A Refreshing Discovery, Inc.

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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CaraDerma acne treatment

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

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

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

CaraDerma Carton Label

Carton Label

CARADERMA 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51130-333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE1.125 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51130-333-121 in 1 CARTON
115 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D09/02/2010
Labeler - A Refreshing Discovery, Inc. (604440243)
Establishment
NameAddressID/FEIBusiness Operations
Advanced Skin Technologies Inc.176084556MANUFACTURE

Revised: 10/2010
Document Id: 98f9f508-2419-4c45-aee4-4c0974423010
Set id: 49d23e94-052b-46ea-8770-b4fd86e09a0c
Version: 2
Effective Time: 20101004
 
A Refreshing Discovery, Inc.