Your browser does not support JavaScript! SEPHORA ACNE-FIGHTING ROLL-ON (SALICYLIC ACID) GEL [S+]
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SEPHORA ACNE-FIGHTING ROLL-ON (salicylic acid) gel
[S+]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

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

  • formulated without parabens.  Non-comodogenic and dermatologically tested, suits even sensitive skin
  • contains salicylic acid to purify skin and reduce breakouts after the 1st application.  Contains HydroSenn+TM, an ultra moisturizing ingredient to keep skin from drying out.
  • roll-on applicator allows ultra targeted application on acne spots.  Slip it into a purse and take it everywhere!  Morning and night, apply directly on breakouts.  Rub the gel with roll-on applicator.
DEMONSTRATED RESULTS!
After 8 hours:
  • reduction of the size of acne breakouts by 60%(1)
After 28 days:
Women noticed
  • reduction of the number of acne spots: 70% (2)
  • breakouts disappeared without leaving marks:  74% (2)
(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
  • formulated without parabens
  • suits all skin types, even sensitive skin
Effective
  • HydroSenn+TM: an ultra moisturizing natural ingredient that is more effective than hyaluronic acid
  • clinically tested by independent laboratories.

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:31720-203
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
C13-14 ISOPARAFFIN 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
PHENOXYETHANOL 
GLYCERIN 
LAURETH-7 
BUTYLENE GLYCOL 
SODIUM HYDROXIDE 
PANTHENOL 
GLYCYRRHIZA GLABRA 
SENNA ALEXANDRINA SEED 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31720-203-0610 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/12/2012
Labeler - S+ (572406531)
Registrant - S+ (572406531)
Establishment
NameAddressID/FEIBusiness Operations
INTERCOSMETIQUES390266153manufacture(31720-203)

Revised: 11/2012
 
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