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CaraDerma

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 1.125g in 15g
Labeler: A Refreshing Discovery, Inc.
NDC Code: 51130-333

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.

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

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:51130-333
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE1.125 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:51130-333-121 JAR (JAR) 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/FEIOperations
Advanced Skin Technologies Inc.176084556MANUFACTURE

Revised: 10/2010
 
A Refreshing Discovery, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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