FDA Label for Acne Treatment

View Indications, Usage & Precautions

Acne Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Big Lots. 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 Ingredients



Benzoyl peroxide 10%


Purpose



Acne medication


Use



for the treatment of acne


Warnings



For external use only


Do Not Use If You



  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When Using This Product



  • skin irritation and dryness is more likely to occur if you use aother topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with eyes, lips and mouth
  • avoid  contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, buring, itching, peeling or posible swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration

Stop Use And Ask A Doctor If



irritation becomes severe


Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin 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 bothersome dryness or peeling occurs, reduce daily application to once a day or every other day
  • if going outside, apply sunscreen after using this product.  If irritation or sensitivity develops stop use of both products and ask a doctor

Inactive Ingredients



carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water


Questions?



1-888-593-0593


Claims



This acne medication contains maximum strength benzoyl peroxide.  Themicronized benzoyl peroxide formula goes to work immediately, releasing the medicine deep into the pore where pimples begin


Adverse Reactions Section



Manufacture for Big Lots by: Vi-Jon, inc.

8515 Page Avenue, St. Louis, MO 63114

Made in the USA with US and foreign components


Disclaimer



This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Clean & Clear Persa-Gel 10.


Principal Display Panel



SOUND

BODY

COMPARE TO

CLEAN & CLEAR

PERSA-GEL 10

10% Benzoy Peroxide

ACNE MEDICATION

MAXIMUM STRENGTH

SOUND

BODY

10% Benzoyl Peroxide

ACNE MEDICATION

MAXIMUM STGRENGTH

NET WT. 1 OZ (28g)


* Please review the disclaimer below.