Label: CHAMOIS GLIDE- 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 December 6, 2009

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  • SPL UNCLASSIFIED SECTION

  • 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
    • 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.

  • Inactive Ingredients

    aloe barbadensis leaf juice, C18-36 acid triglyceride, capric/caprylic triglycerides, fragrance, yellow 11 (CI 47000), green 6 (CI 61565), tocopheryl acetate, tribehenin

    Questions +1 425.467.6580

    Distributor: Bodyglide, Bellevue, WA USA

    © 2009 W Sternoff LLC Made in Canada

  • Principal Display Panel

    minty fresh

    new endurance formula

    apply directly to skin, shorts, chamois
    stop saddle sores    ™

    No messy cream

    No greasy butter

    invisible

    no water

    no lanolin

    no petroleum

    no mineral oil

    reliable since 1996

    apply once

    ride longer

    NET WT. 0.45 oz (12.8 g)

    Principal Display Panel minty fresh new endurance formula apply directly to skin, shorts, chamois stop saddle sores™ No messy cream No greasy butter invisible no water no lanolin no petroleum no mineral oil reliable since 1996 apply once ride longer NET WT. 0.45 oz (12.8 g)

  • INGREDIENTS AND APPEARANCE
    CHAMOIS GLIDE 
    allantoin stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15197-008
    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)  
    D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
    D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15197-008-141 in 1 PACKAGE
    1NDC:15197-008-1336.9 g in 1 TUBE
    2NDC:15197-008-261 in 1 PACKAGE
    2NDC:15197-008-2570 g in 1 TUBE
    3NDC:15197-008-461 in 1 PACKAGE
    3NDC:15197-008-4512.8 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34711/24/2009
    Labeler - W STERNOFF LLC (006801828)
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