Label: FLUSHABLE WIPES- dimethicone gel

  • 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 January 6, 2018

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  • Active Ingredient

    Dimethicone 3.2%

  • Purpose

    Skin Protectant

  • Use

    provides temporary relief to irritated skin

  • Warning

    For external use only
    Do not use on

    Large cuts or wounds

    severe burns

    eyes or near mouth

    stop use and call a doctor if

    symptoms last for greater than 7 days or reoccur after clearing up

    Keep out of reach of children ,seek medical attention if swallowed

  • Directions

    peel back sticker

    clean affected area with wipe

    dispose of wipe properly

    reseal label

  • INACTIVE INGREDIENT

    Aqua
    Glycerin
    Propylene Glycol
    Polyaminopropyl Biguanide
    Polysorbate 20
    Allantoin
    Chlorphenesin
    Decyl Glucoside
    2-Bromo-2-Nitropropane-1,3-Diol
    Sodium Citrate

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    FLUSHABLE WIPES 
    dimethicone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69392-901
    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
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69392-901-0124 in 1 CARTON07/29/2017
    1290 g in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/29/2017
    Labeler - SVS, LLC (DBA S2S Global) (831375089)
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