SEPHORA ACNE-FIGHTING ROLL-ON  - salicylic acid gel 
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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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SEPHORA Acne-Fighting Roll-On Gel

SEPHORA Acne-Fighting Roll-On Gel


Salicylic Acid  2%

Purpose

Acne Treatment

Use

For the treatment of acne.

Warnings

For external use only.

When using this product

  • skin irritation and dryness in more likely 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 reach of children.

If swallowed, get medical help or contact Poison Control center right away.

Directions

Inactive Ingredients

water, alcohol, acrylamide/sodium acryloyldimethyltaurate copolymer, c13-13 isoparaffin, peg-40 hydrogenated castor oil, phenoxyethanol, glycerin, laureth-7, fragrance, butylenes glycol, sodium hydroxide, panthenol, licorice (glycyrrhiza glabra) root extract, senna (cassia angustifolial) seed polysaccharide.

WHY WE LOVE IT

DEMONSTRATED RESULTS!
After 8 hours:
After 28 days:
Women noticed
(1) Scientific test on 22 volunteers,
(2) % of users satisfied.  In use test on 22 volunteers.

S+, 70 Avenue des Champs-Elysees, F-75008 Paris, France, Dist. by Sephora USA, 525 Market Street, 32nd Floor, San Francisco, CA 94105.  made in France.
To report a serious adverse event, contact Sephora USA.


100%  Gentle
Effective

SEPHORA   Roll-on stop acne  Acne-fighting roll-on gel   spot be gone   Acne Treatment  2% Salicylic Acid   1 problem: 1 solution     Dermatologically tested   10ml 0.33 fl. oz.

SEPHORA Acne-Fighting Roll-On Gel 10ml (31720-203-06)

Inner PackageOuter Package

SEPHORA ACNE-FIGHTING ROLL-ON  
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:31720-203
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURETH-7 (UNII: Z95S6G8201)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PANTHENOL (UNII: WV9CM0O67Z)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SENNA ALEXANDRINA SEED (UNII: UC1K4NA7ML)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:31720-203-06 10 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 11/12/2012
Labeler - S+ (572406531)
Registrant - S+ (572406531)
Establishment
Name Address ID/FEI Business Operations
INTERCOSMETIQUES 390266153 manufacture(31720-203)

Revised: 11/2012
Document Id: 6821ae4f-76b5-4f25-af79-727d94ed7335
Set id: 83038e47-760f-402c-a91d-cb945c8c462e
Version: 1
Effective Time: 20121112
 
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