Label: RUN GUARD ORIGINAL- 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 August 26, 2014

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Allantoin 0.5%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    Helps prevent skin chafing during exercise

  • WARNINGS

    Warnings

    For external use only.

    Not intended as a treatment for rashes, sores or open cuts. Do not ingest or allow contact with eyes. Stop use if rash or irritation occurs.

    Keep out of reach of children.

    In case of ingestion, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply to underarms, inner thighs, toes, heels, groin or other areas as necessary.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Beeswax, Capric/Caprylic Triglycerides, Organic Carnauba Wax, Tocopheryl Acetate (Vitamin E), Tribehenin

  • QUESTIONS

    Questions?

    1-877-369-1600 U.S. toll free

    1-734-544-4490 International

  • PRINCIPAL DISPLAY PANEL

    UNSCENTED

    All Weather, Any Distance

    Anti-Chafe Stick

    +Run

    Guard

    with

    Aloe

    Beeswax and

    Organic Carnauba

    Net Weight

    2.7 oz (76g)

    MADE IN USA

    container label

  • INGREDIENTS AND APPEARANCE
    RUN GUARD ORIGINAL 
    allantoin stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24474-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24474-001-0176 g in 1 TUBE
    2NDC:24474-001-0214 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2012
    Labeler - RunGuards LLC (048774926)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alliant Manufacturing, LLC078890221manufacture(24474-001)