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Name:Blemish Treatment
Manufacturer:Neostrata Company Inc
Category:Over-the-counter (OTC) Marketed Drugs


Exuviance® Blemish Treatment Gel

BLEMISH TREATMENT - salicylic acid gel 
NeoStrata Company Inc

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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Exuviance®
Blemish Treatment Gel

Drug Facts

Active ingredient

Salicylic Acid 2.0%

Purpose

Acne treatment

Uses

  • clears acne blemishes, acne pimples, blackheads and whiteheads
  • allows skin to heal
  • helps prevent new acne blemishes from forming

Warnings

For external use only

Do not use during pregnancy/ lactation. Contains peanut oil.

When using this product

  • using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. Only one drug should be used unless directed by a doctor.

Stop use and ask a doctor if

  • too much skin irritation or sensitivity develops or increases

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Flammable

keep away from fire or flame.

Directions

  • clean the skin thoroughly before applying medication
  • using fingertip, cover the entire affected area with a thin layer 1 to 3 times daily
  • because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor
  • if bothersome peeling or dryness occurs, reduce applications to once a day or every other day
  • for new users, apply product sparingly to 1 or 2 small affected areas for approximately 3 days. If no discomfort occurs, follow directions above.

Other information

  • Store at 20°C-25°C (68°F-77°F)
  • You may report serious side effects to 1-800-628-9904

Inactive ingredients

Acetyl Mandelic Acid, Alcohol Denat., Butylene Glycol, C13-14 Isoparaffin, Citric Acid, Laureth-7, PEG-8, Polyacrylamide, Propylene Glycol, Retinyl (Vitamin A) Acetate/Arachis Hypogaea (Peanut) Oil, Tartaric Acid.

Mfd. for NeoStrata Co., Inc.,
Princeton, NJ 08540 USA

PRINCIPAL DISPLAY PANEL - 15 g Carton

DERMATOLOGIST DEVELOPED
Exuviance®

Blemish Treatment Gel

oily / acne prone

Salicylic acid acne
treatment

On the spot treatment
penetrates pores to clear
acne blemishes

Net Wt 0.5 oz/ 15 g

Principal Display Panel - 15 g Carton

BLEMISH TREATMENT 
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58414-8712
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic Acid (Salicylic Acid) Salicylic Acid 0.02 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
Alcohol  
Propylene Glycol  
Butylene Glycol  
POLYETHYLENE GLYCOL 400  
C13-14 Isoparaffin  
Vitamin A Acetate  
Peanut Oil  
Laureth-7  
Anhydrous Citric Acid  
Tartaric Acid  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58414-8712-1 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (58414-8712-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 10/30/2010

Labeler - NeoStrata Company Inc (605754829)
Establishment
Name Address ID/FEI Operations
COSMETIC ESSENCE, LLC 825646862 MANUFACTURE

Revised: 11/2010 NeoStrata Company Inc



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


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