Label: INFLAMMATION OTC- allantoin lotion

  • 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 January 16, 2011

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  • Active ingredient

    Allantoin (0.5%)


  • Purpose

    Skin protectant

  • Uses

    Temporarily protects minor: burns, cuts, and scrapes

    Temporarily protects and helps relieve
    • chapped skin
    • cracked skin

       
  • Warnings

    For external use only

    When using this product

    • do not get into eyes
  • Keep out of reach of children

    In case of accidental ingestion seek professional assistance or contact a poison control center immediately.

  • Directions

    • Apply as needed
    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
  • Inactive ingredients

    water, glycerin, helianthus annuus (sunflower) seed oil, glyceryl laurate, glycine soja (soybean) oil, cetearyl alcohol, panthenol, ceteareth 20, caprylic/capric triglyeride, sorbitol, cetyl ricinoleate, rosmarinus officinalis (rosemary) leaf, tocopherol, squalane, bisabolol, C10-30 cholesterol/lanosterol esters, algae extract,sodium carboxymethly starch, camelia sinensis leaf extract, triticum vulgare (wheat) germ extract, uncaria tomentosa extract, sodium hyaluronate, calendula officinalis flower extract, yeast extract, lavandula angustifolia (lavender) oil, lactobacillus/bean seed extract/sodium glutamate ferment filtrate, petasites japonicus (butterbur) root extract, glycine soja (soybean) seed extract, phytosphingosine HCl, cholesterol, sodium lauroyl lactylate, carbomer, ceramide 3, saccharide isomerate, ceramide 6, ceramide 1, foeniculum vulgare (fennel) fruit extract, saccharomyces/copper ferment, saccharomyces/manganese ferment, saccharomyces/zinc ferment, xanthan gum, glycereth-7 trimethyl ether, phenoxyethanol, iodopropynyl butylcarbmate

  • Questions or comments

    call 1-912-236-9430 weekdays

  • Principal Display Panel

    Inflammation OTC

    Radiation Relief

    Net wt 1 oz. (28.35 mL)

    Manufactured by SkinDeep for SkinFit Distributors

    Savannah, GA 31405

    Tel: 912-236-9430

    www.mwlabs.com


    Inflammation OTC Box


  • INGREDIENTS AND APPEARANCE
    INFLAMMATION OTC   RADIATION RELIEF
    allantoin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45156-5616
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin3 g  in 600 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Helianthus Annuus (UNII: BKJ0J3D1BP)  
    Glyceryl Laurate (UNII: Y98611C087)  
    Soybean Oil (UNII: 241ATL177A)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Dexpanthenol (UNII: 1O6C93RI7Z)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Sorbitol (UNII: 506T60A25R)  
    Ricinoleic Acid (UNII: I2D0F69854)  
    Rosemary Oil (UNII: 8LGU7VM393)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    Squalane (UNII: GW89575KF9)  
    .Alpha.-Bisabolol, (+/-)- (UNII: 36HQN158VC)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Triticum Aestivum Pollen (UNII: F1KAH8374D)  
    Cat's Claw (UNII: 9060PRM18Q)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45156-5616-21 in 1 BOX
    1NDC:45156-5616-129 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/13/2010
    Labeler - Skin Deep (833276566)
    Establishment
    NameAddressID/FEIBusiness Operations
    Skin Deep833276566manufacture
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