FDA Label for Caraderma

View Indications, Usage & Precautions

Caraderma Product Label

The following document was submitted to the FDA by the labeler of this product A Refreshing Discovery, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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