Label: MONISTAT COMPLETE CARE CHAFING RELIEF- dimethicone gel

  • NDC Code(s): 57501-087-01
  • Packager: Apex International Mfg., LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Monistat Care Chafing Relief Powder Gel®

    Drug Facts

  • Active ingredient

    Dimethicone 1.2%

  • Purpose

    Skin Protectant

  • Use

    • Temporarily protects and helps relieve chafed, chapped or cracked skin.
  • Warnings

    For external use only.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    do not get into eyes.

    Stop use and ask a doctor if

    • condition 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 (1-800-222-1222) right away.

  • Directions

    Apply as needed.

  • Other information

    Store at 20˚-25˚C (68˚-77˚F)

  • Inactive ingredients

    cyclomethicone, dimethicone, dimethicone/vinyl dimethicone crosspolymer, silica dimethyl silylate, vinyl dimethicone/methicone silsesquioxane crosspolymer 

  • Questions?

    1-877-666-4782 Monistat.com

  • PRINCIPAL DISPLAY PANEL

    MONISTAT
    Care®
    Chafing Relief
    Powder Gel®
    Dimethicone/Skin Protectant
    Dimeticona / Protector Para La Piel
    NET WT / PESA NETO 1.5 oz (42g)

    Label
  • INGREDIENTS AND APPEARANCE
    MONISTAT COMPLETE CARE CHAFING RELIEF 
    dimethicone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57501-087
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57501-087-011 in 1 CARTON01/08/2024
    142 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/08/2024
    Labeler - Apex International Mfg., LLC (015226132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apex International Mfg., LLC015226132label(57501-087) , manufacture(57501-087) , pack(57501-087)
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