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

BLEMISH TREATMENT
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58414-8712
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	0.02 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Alcohol (UNII: 3K9958V90M)
Propylene Glycol (UNII: 6DC9Q167V3)
Butylene Glycol (UNII: 3XUS85K0RA)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Vitamin A Acetate (UNII: 3LE3D9D6OY)
Peanut Oil (UNII: 5TL50QU0W4)
Laureth-7 (UNII: Z95S6G8201)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Tartaric Acid (UNII: W4888I119H)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58414-8712-1	1 in 1 CARTON	10/30/2010	04/30/2019
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	10/30/2010	04/30/2019

Labeler - NeoStrata Company Inc (605754829)

Revised: 5/2018

Document Id: 633058c4-6477-4827-85b5-729bf2791618

Set id: 89f2576f-3be2-4df1-8617-0b7921042946

Version: 2

Effective Time: 20180508

NeoStrata Company Inc