Label: APPLICELL ADVANCED- dimethicone 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 November 25, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 3.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Hydrogenated Polydecene, Triethylhexanoin, Butylene Glycol, Glycerin, Citrus Paradisi (Grapefruit) Fruit Extract, PEG-5 Glyceryl Stearate , PEG-100 Stearate, Glyceryl Stearate, Isostearic Acid, Stearic Acid, Macadamia Ternifolia Seed Oil, Betaine, Trehalose, Glyceryl Stearate SE, Behenic Acid, Behenyl Alcohol, Human fibroblast Conditioned Media, Neofinetia Falcata Callus Culture Extract, Phenoxyethanol, Fragrance, Carbomer, Portulaca Oleracea Extract, Hydrolyzed Keratin, Hydrolyzed Collagen, Hydrolyzed Elastin, Coix Lacryma-Jobi Ma-yuen Seed Extract, Potassium Hydroxide, Trisodium EDTA, Caprylhydroxamic Acid, Caprylyl Glycol

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only When using this product do not get into eyes, Stop use and ask a doctor if rash occurs Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & usage: APPLICELL Advanced Lotion is available to nourish to the skin and brings a soft, moist feel.

  • DOSAGE & ADMINISTRATION

    How to use: After serum, take proper amount and apply over the face along skin texture.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    APPLICELL ADVANCED 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71098-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone4.55 g  in 130 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71098-010-021 in 1 CARTON10/10/2016
    1NDC:71098-010-01130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/10/2016
    Labeler - Anc HnB Inc. (689031836)
    Registrant - Anc HnB Inc. (689031836)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anc HnB Inc.689031836manufacture(71098-010)
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