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Name:Asepxiafacial Cleansing
Manufacturer:Fischer Pharmaceuticals Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Asepxia

ASEPXIA FACIAL CLEANSING - salicylic acid  cloth 
Fischer Pharmaceuticals Ltd.

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.

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Asepxia

Drug Facts

Active ingredient                         Purpose

Salicylic acid 0.5%................ Acne Treatment

Uses

Enter section text here

  • for the treatment of acne

Warnings

For external use only

When using this product

skin irritation and 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.

Keep out of the 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 both some dryness or peeling occurs, reduce application to once a day or every other day.
Sensitivity Test for a 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

Store in a cool dry place. Keep outer packaging for precautions and directions

Inactive ingredients

water, alcohol denatured (20% vlv), hamamelis virginiana (witch hazel) extracts, polysorobate 20, propylene glycol, sodium citrate, fragrance, panthenol, Disodium EDTA, chamomila recutita (matricaria) flower extract, 2-bomo-2-nitropropane-1-3-diol, iodopropynyl butylcarbamate, glycolic acid.

Questions or comments?

1 877 99 GENOM (4366)

(front of packet)

Remove oil and dirt

For the treatment of Acne

Content: 10 Wipes

(back of packet)

Made in Israel

Distributed by

Televisa Consumer Products

USA, LLC 4550 Post Oak Place

Suite 326 Houston, TX 77027

Lot No

Exp.:

Packet Label - Front & Back


ASEPXIA  FACIAL CLEANSING
salicylic acid cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59886-410
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
ALCOHOL  
HAMAMELIS VIRGINIANA LEAF  
POLYSORBATE 20  
PROPYLENE GLYCOL  
SODIUM CITRATE  
PANTHENOL  
EDETATE DISODIUM  
CHAMOMILE  
BRONOPOL  
IODOPROPYNYL BUTYLCARBAMATE  
GLYCOLIC ACID  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59886-410-10 53 g in 1 PACKET None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 01/30/2011

Labeler - Fischer Pharmaceuticals Ltd. (600158976)
Establishment
Name Address ID/FEI Operations
Fischer Pharmaceuticals Ltd. 600158976 manufacture

Revised: 01/2011 Fischer Pharmaceuticals Ltd.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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