Label: ANTI-CHAFE STICK PRO SERIES- allantoin stick 

  • NDC Code(s): 76347-125-01, 76347-125-02
  • Packager: Mission Product Holdings
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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  • ACTIVE INGREDIENT

    Active ingredients               Purpose

    Allantoin (0.5%)                Skin protectant




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    Uses: Helps Prevent and temporarily relieve chafed, chapped or cracked skin

    Helps protect from the drying effects of wind and cold weather

    Temporarily protects minor cuts, scrapes , burns

    Keep out of reach of children

    Stop use and ask a doctor if

    Conditions worsens

    symptoms last more than 7 days or clear up and occur again within a few days

    Warnings: For external use only

    When using this product: do not get into eyes

    Do not use on: deep puncture wounds, Animal bites , Serious burns

    If swallowed,get medical or contact Poison Control Center

    Directions: apply as needed


    Inactive ingredients: Glycine soja (soybean) oil, hydrogenated cottonseed oil, dicaprylyl carbonate, beeswax, cyclopentasiloxane, stearyl alcohol, Euphorbia Cerifera (candelilla) wax, ozokerite, talc, silica, dimethicone, butyrospermum parkii (shea butter), tocopheryl acetate, retinyl palmitate, pyridoxine HCL, Sodium ascorbyl phosphate, cholecalciferol, zea mays (corn) oil, phytonidone, aloe barbadensis leaf extract, euterpe oleracea seed oil, punica granatum seed oil, vaccinium macrocarpon (cranberry) seed oil, carthamus tinctorius (safflower) seed oil, lycium barbarum fruit extract.


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  • PRINCIPAL DISPLAY PANEL

    5 hour (TM)

    Anti-chafe stick

    Pro series


    Net. Wt. 1.5 oz (42 G)




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  • INGREDIENTS AND APPEARANCE
    ANTI-CHAFE STICK  PRO SERIES
    allantoin stick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76347-125
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALLANTOIN (ALLANTOIN) ALLANTOIN 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    HYDROGENATED COTTONSEED OIL  
    DICAPRYLYL CARBONATE  
    CYCLOMETHICONE 5  
    STEARYL ALCOHOL  
    CANDELILLA WAX  
    CERESIN  
    TALC  
    SILICON DIOXIDE  
    DIMETHICONE  
    SHEA BUTTER  
    VITAMIN A PALMITATE  
    PYRIDOXINE HYDROCHLORIDE  
    SODIUM ASCORBYL PHOSPHATE  
    CHOLECALCIFEROL  
    ALOE VERA LEAF  
    POMEGRANATE SEED OIL  
    CRANBERRY SEED OIL  
    SAFFLOWER OIL  
    LYCIUM BARBARUM FRUIT  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76347-125-02 1 in 1 BLISTER PACK
    1 NDC:76347-125-01 42 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 07/26/2011
    Labeler - Mission Product Holdings (808672120)
    Registrant - Mission Product Holdings (808672120)
    Establishment
    Name Address ID/FEI Business Operations
    Body Blue 2006 inc 243094112 manufacture(76347-125)
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