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Blemish Treatment

Dosage form: gel
Ingredients: Salicylic Acid 0.02g in 1g
Labeler: NeoStrata Company Inc
NDC Code: 58414-8712

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.

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

BLEMISH TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58414-8712
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Propylene Glycol 
Butylene Glycol 
POLYETHYLENE GLYCOL 400 
C13-14 Isoparaffin 
Vitamin A Acetate 
Peanut Oil 
Laureth-7 
Anhydrous Citric Acid 
Tartaric Acid 
Packaging
#Item CodePackage Description
1NDC:58414-8712-11 TUBE (TUBE) in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/30/2010
Labeler - NeoStrata Company Inc (605754829)
Establishment
NameAddressID/FEIOperations
COSMETIC ESSENCE, LLC825646862MANUFACTURE

Revised: 11/2010
 
NeoStrata Company Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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