Label: ANTI CHAFE BALM- allantoin stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 6, 2010

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient:

    Allantoin 0.5%

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  • Purpose:

    Skin Protectant

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  • 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
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  • 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.

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  • Directions

    Apply as needed.

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  • Other Information

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

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

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  • Questions: 

    (888) 263-9454

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  • 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

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  • INGREDIENTS AND APPEARANCE
    ANTI CHAFE BALM 
    allantoin stick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52342-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52342-001-01 1 in 1 BOX
    1 36.9 g in 1 TUBE
    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)
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