Label: ADULT WASH GLOVES WITH SKIN PROTECTANT- dimethicone cloth

  • 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 22, 2022

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  • DRUG FACTS Active Ingredient

    Dimethicone 3% (w/w)

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve dry or cracked skin

    Beneficial for face, hands, body, and legs

  • Warnings

    For external use only.

  • Do not use

    on deep or pouncture wounds

    on animal bites

    on serious burns

  • When using this product

    Do not get into eyes

  • Stop use and ask a doctor if

    • contition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison control center right away.

  • Directions

    Open package at the top and remove one glove at a time

    Place the glove on your hand and use directly on the skin you wish to clean. Multiple gloves may be required for large soiled areas to avoid cross-contamination and spreading of germs.

    If you wish to warm the gloves before use, follow the mircrowave instructions on the right of the pack.

    Use as frequently as needed.

  • Other information

    Store at room temperature

  • Inactive ingredients

    Water, fragrance, panthenol, glycerin, allantoin, tocopheryl acetate, aloe barbadensis extract, chamomilla recutita extract, chlorhexidine digluconate, polysorbate 20, linoleanmidopropyl PG dimonium chloride phosphate, lauryl glucoside, citric acid, phenoxyethanol, ethylhexylglycerin

  • Label Images

    Adult Wash Gloves

    81310-010-10

    10 count

    label

  • INGREDIENTS AND APPEARANCE
    ADULT WASH GLOVES WITH SKIN PROTECTANT 
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81310-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81310-010-0120 g in 1 PACKET; Type 0: Not a Combination Product12/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/13/2021
    Labeler - Stretton Online Ltd. (220633327)
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