SUPER BUMP RELIEF- benzoyl peroxide and salicylic acid cream

Super Bump Relief by

Drug Labeling and Warnings

Super Bump Relief by is a Otc medication manufactured, distributed, or labeled by Elements Personal Care, Inc., Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

 

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

INGREDIENTS AND APPEARANCE

SUPER BUMP RELIEF 
benzoyl peroxide and salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65840-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	4 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65840-100-01	113 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333D	06/08/2011

Labeler - Elements Personal Care, Inc. (018721058)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	MANUFACTURE