SUPER BUMP RELIEF- benzoyl peroxide and salicylic acid cream 
Elements Personal Care, 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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Super Bump Relief

Active ingredient

Benzoyl Peroxide 4%

Salicylic Acid 3%

Purpose

Elimination of razor bumps and prevention of ingrown hairs

Uses

Elimination of razor bumps and prevention of ingrown hairs

Warnings

Avoid contact with eyes or fabric.

Keep out of reach of children.

Directions

After shaving with a razor or clippers, apply SBR on the entire shaved area, exfoliate with finger tips for 5 minutes, then rinse well or remove with a white wet cloth. In case of severe out-break of folliculitis, apply SBR, exfoliate and leave on overnight and remove with white wet cloth in the morning.

Inactive ingredients

Water (Aqua), Glycerin, Alcohol Denat, Propylene Glycol, Magnesium Sulfate Hepta-hydrate, Triethanolamine, Aloe Barbadensis Leaf Extract, Methylparaben, Hamamelis Virginiana (Witch Hazel) Extract, Cinnamomum Camphora (Camphor) Oil, Xanthan Gum, Carbomer, Titanium Dioxide, Magnesium Aluminum Silicate, Imidazolidinyl Urea.

Package/Label Principal Display Panel - Bottle Label

 

Package/Label Principal Display Panel - Bottle Label

Bottle Label

Super Bump Relief

Developed for

The Elimination of Razor Bumps

and

The Prevention of Ingrown Hairs

Doctor Recommended

Net Wt. 4 oz. (112.9 gr.)

Manufactured: Elements Inc.

N.D.C. 65840

Maxamillion's Gentlemen's Quarters

Barber Parlor

SUPER BUMP RELIEF 
benzoyl peroxide and salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65840-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE4 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CAMPHOR OIL (UNII: 75IZZ8Y727)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
IMIDUREA (UNII: M629807ATL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65840-100-01113 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D06/08/2011
Labeler - Elements Personal Care, Inc. (018721058)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing, Inc.793406000MANUFACTURE

Revised: 6/2011
Document Id: 98963a9d-ade4-4254-ab78-64830dd0d15b
Set id: 98963a9d-ade4-4254-ab78-64830dd0d15b
Version: 1
Effective Time: 20110606
 
Elements Personal Care, Inc.