Label: APPLE BUBBLE- glycerin injectable foam

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 19, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Glycerin 10.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis Leaf Water, Sodium Cocoyl, Apple Amino Acids, Sodium Lauroyl Aspartate, Hydrogenated Starch Hydrolysate, Glycosyl Trehalose, Pinus Palustris leaf extract, Citrus Grandis Seed Extract, Bambusa Textilis Stem Extract

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:

    1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight 4. Be aware not to get into eye.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Usage

    Usage: Get decent amount of foam by pumping a container. Gently apply it along the skin texture as if massage is given and cleanse it.

  • Usage

    Usage: Get decent amount of foam by pumping a container. Gently apply it along the skin texture as if massage is given and cleanse it.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    APPLE BUBBLE 
    glycerin injectable foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70380-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin12 g  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70380-130-01120 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/02/2016
    Labeler - MIGUHARA (689204213)
    Registrant - MIGUHARA (689204213)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIGUHARA689204213manufacture(70380-130)
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