FDA Label for Ct07 Benzoyl Peroxide Treatment

View Indications, Usage & Precautions

Ct07 Benzoyl Peroxide Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Pharmco Laboratories, 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.

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DRUG FACTS


Active Ingredient



2.5% Benzoyl Peroxide


Purpose



Acne Treatment


Uses



For the treatment of acne


Warnings



  • For external use only.

Otc - Do Not Use



Do not use if you

  • Have very sensitive skin.
  • Are sensitive to benzoyl peroxide.

Otc - When Using



When using this product

  • Skin irritation & dryness is more likely to occur if you use another 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 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, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in lower concentration.
  • If going outside, apply sunscreen after using this product.

Otc - Stop Use



  • Stop use and ask a doctor if irritation becomes severe.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children.
  • If swallowed get medical help or call a poison control center immediately.
  • Keep away from excessive heat or heat sources.

Directions



  • Clean the skin thoroughly before applying this product.
  • Clover the entire affected area with a thin layer one to three times per day.
  • 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 bothersome dryness and peeling occurs, reduce 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 both products and ask doctor.

Other Ingredients



Carbomer, Edetate Disodium, Glycerine, Propylene Glycol, Saccharide Isomerate, Sodium Hydroxide, Water


Other Information



Store at 15 - 25°C (59 - 77°F)
Protect from heat.
Keep container tightly closed.


Principal Display Panel - 60 G Tube Carton



clearup

Anti-acne
Clearing Gel

Micronized
Benzoyl Peroxide

2.5%

PREVENTS & TREATS BREAKOUTS

MADE IN THE USA
ADVANCED FORMULA
GEL TEXTURE

60g / 2.1 oz


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