Label: SKIN PROTECTANT FLUSHABLE WIPES- dimethicone liquid

  • 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 December 27, 2017

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  • Skin Protectant Flushable Wipes


  • Active Ingredient

    Dimethicone 3.2%

  • Purpose

    Skin Protectant

  • Use

    Temporarily protects and helps relieve chapped or cracked skin

  • Warnings

    For external use only

    When using this product do not get into eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days to clear up and occur again within a few days
    • irritation or redness develops

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • Open package as designated
    • Remove cloth and apply to the soiled area
    • Apply as needed
    • Dispose of cloth in waste receptacle or flush in toilet
  • Other Information

    Store at room temperature

  • Inactive Ingredients

    WATER, SODIUM COCO PG-DIMONIUM CHLORIDE PHOSPHATE, LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, POLYSORBATE-20, DISODIUM EDTA, CETEARYL ISONONANOATE, CETEARETH-20, CETEARYL ALCOHOL, GLYCERYL STEARATE, CETEARETH-12, CETYL PALMITATE, GLYCERIN, SODIUM BENZOATE, BENZALKONIUM CHLORIDE, PHENOXYETHANOL, ALOE VERA LEAF JUICE, CITRIC ACID

  • Skin Protectant Flushable Wipes 24 Wipes (44019-004-00)

    Skin Protectant Flushable Wipes

  • INGREDIENTS AND APPEARANCE
    SKIN PROTECTANT FLUSHABLE WIPES 
    dimethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44019-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44019-004-0024 in 1 BAG08/03/2016
    112.33 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/03/2016
    Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
    Registrant - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
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