Label: SELLA NATURAL BABY- glycerin lotion

  • 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 February 11, 2015

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  • ACTIVE INGREDIENT

    glycerine


  • INACTIVE INGREDIENT

    water, butylene glycol, panthenol etc


  • PURPOSE

    skin protectant


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    apply to the skin and rub gently and wash away


  • WARNINGS

    ・Stop using the product when you have skin problems or the product disagrees with your skin
    ・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
    ・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.


  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    SELLA NATURAL BABY 
    glycerin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69603-0801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69603-0801-1120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/01/2014
    Labeler - Sella Natural Cosmetics Co.,Ltd. (687563333)
    Registrant - Sella Natural Cosmetics Co.,Ltd. (687563333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sella Natural Cosmetics Co.,Ltd.687563333manufacture(69603-0801)
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