FDA Label for Asepxia Acne Treatment

View Indications, Usage & Precautions

Asepxia Acne Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa 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

Distributed by: Genomma Lab USA Inc., Houston, TX 77027


Active Ingredient



Brnzoyl Peroxide 10%


Purpose



Acne Treatment


Uses



  • ♦for the treatment of acne
  • ♦dries and clears acne blemishes
  • ♦penetrates pores to eliminate most acne blemishes
  • ♦helps prevent new acne blemishes

Warnings



For external use only


Do Not Use



  • ♦if you have very sensitive skin
  • ♦if you are sensitive to benzoyl peroxide

When Using This Product



  • ♦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 and dryness is more likely to occur if you use another acne medication at the same time. If irritation occurs, use only one topical acne medication at a time
  • ♦skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using this product less frequently or at 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 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

Sensitivity Test For New User



  • ♦apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above

Other Information



  • ♦Keep tightly closed
  • ♦Store at room temperature

Inactive Ingredients



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


Questions Or Comments?



1 877 99 GENOM (43666)


Principal Display Panel - 28 G Tube Carton



NEW LOOK

Asepxia®

ACNE TREATMENT CREAM

10% BENZOYL PEROXIDE

> ELIMINATES MOST PIMPLES AND BLACKHEADS

NET WT.
1 OZ (28 g)


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