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Blemish Treatment

NeoStrata Company Inc

Exuviance Blemish Treatment Gel


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Salicylic Acid 2.0%

Purpose

Acne treatment

Blemish 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.

Blemish Treatment 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

Blemish Treatment

Salicylic Acid GEL

Product Information

Product Type Human otc drug label 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 0.02 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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 TUBE
2 NDC:58414-8712-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2010-10-30


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Be sure to consult your doctor before taking any medication!
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