Label: ANTI CHAFE BALM- allantoin stick

  • Category: HUMAN OTC DRUG LABEL

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

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  • SPL UNCLASSIFIED SECTION

    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

  • INGREDIENTS AND APPEARANCE
    ANTI CHAFE BALM 
    allantoin stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52342-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52342-001-011 in 1 BOX
    136.9 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34707/01/2010
    Labeler - Hickory Brands Inc. (192370542)
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