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Name:Anti Chafe Balm
Manufacturer:Hickory Brands Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Anti-Chafe Balm

ANTI CHAFE BALM - allantoin stick 
Hickory Brands 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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Anti-Chafe Balm

Drug Facts

Active Ingredient:

Allantoin 0.5%

Purpose:

Skin Protectant

Uses:

  • helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
  • temporarily protects minor cuts, scrapes, burns

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.

Other Information

  • Store at 59º – 86º F (15º - 30º C)
  • may stain some fabrics

Inactive Ingredients:

aloe barbadensis (aloe vera) leaf juice, C18-36 acid triglycerides, caprylic/capric triglycerides, tocopheryl acetate, tribehenin

Questions: 

(888) 263-9454

Principal Display Panel

NB new balance.
anti-chafe

balm

BodyGlide®
helps
prevent

&
 relieve
chafed

chapped

cracked

skin

no mess

no oils or

petroleum

sweat

& water

resistant

Net Wt. 1.3 oz (36.9 g)

Principal Display Panel
BodyGlide anti-chafe balm


ANTI CHAFE BALM 
allantoin stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52342-001
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 VERA LEAF  
MEDIUM-CHAIN TRIGLYCERIDES  
.ALPHA.-TOCOPHEROL ACETATE, D-  
TRIBEHENIN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52342-001-01 1 TUBE (1 TUBE) in 1 BOX contains a TUBE
1 36.9 g in 1 TUBE This package is contained within the BOX (52342-001-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 07/01/2010

Labeler - Hickory Brands Inc. (192370542)

Revised: 06/2010 Hickory Brands Inc.



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


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