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Name:Bodyglide Anti Chafe Balm
Manufacturer:W Sternoff Llc
Category:Over-the-counter (OTC) Marketed Drugs


Anti-chafe balm

BODYGLIDE ANTI CHAFE BALM - allantoin stick 
W STERNOFF LLC

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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Anti-chafe balm

Active Ingredient: 

Allantoin 0.5%

Purpose

Skin Protectant

Uses

  • helps prevent and helps relieve chafed, chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather

Warnings

For external use only.

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply as needed.

Inactive Ingredients

aloe barbadensis extract, C18-36 acid triglycerides, caprylic/capric triglycerides, FD & C Red No. 40, tocopheryl acetate, tribehenin

Questions +1 425.467.6580

Distributor: Bodyglide, Bellevue, WA USA

©2009 W Sternoff LLC, Bellevue, WA USA

All rights reserved www.bodyglide.com
Trademarks registered

Made in Canada

Principal Display Panel

BODYGLIDE
anti-chafe balm

Dry, Non-Greasy

helps prevent & relieve

hot spots, chafing, rubbing

feet, mid body, upper body

shoes & all footwear, thighs, saddle sores, bras, under arms
great for daily use

trusted by endurance athletes

sweat & water resistant

Invisible, No Oils, Many apply it just once, Remove with soap and water, Recommended for compression wear, neoprene and wetsuits

Principal Display Panel
BODYGLIDE
anti-chafe balm
Dry, Non-Greasy


BODYGLIDE ANTI CHAFE BALM 
allantoin stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15197-007
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLANTOIN (ALLANTOIN) ALLANTOIN 5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE  
.ALPHA.-TOCOPHEROL ACETATE, D-  
TRIBEHENIN  
MEDIUM-CHAIN TRIGLYCERIDES  
FD&C RED NO. 40  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15197-007-07 2 g in 1 TUBE None
2 NDC:15197-007-14 1 TUBE (1 TUBE) in 1 PACKAGE contains a TUBE (15197-007-13)
2 NDC:15197-007-13 36.9 g in 1 TUBE This package is contained within the PACKAGE (15197-007-14)
3 NDC:15197-007-26 1 TUBE (1 TUBE) in 1 PACKAGE contains a TUBE (15197-007-25)
3 NDC:15197-007-25 70 g in 1 TUBE This package is contained within the PACKAGE (15197-007-26)
4 NDC:15197-007-46 1 TUBE (1 TUBE) in 1 PACKAGE contains a TUBE (15197-007-45)
4 NDC:15197-007-45 12.8 g in 1 TUBE This package is contained within the PACKAGE (15197-007-46)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 11/24/2009

Labeler - W STERNOFF LLC (006801828)

Revised: 12/2009 W STERNOFF LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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