Label: OMV ANTI-ITCH BIKINI- oatmeal cream

  • 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 September 25, 2019

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  • SPL UNCLASSIFIED SECTION

    OMV! by Vagisil™ Bikini Anti-Itch Serum

    DRUG FACTS

  • Active Ingredient

    Colloidal Oatmeal 0.01%

  • Purpose

    Skin Protectant

  • Use

    Provides temporary skin protection and relief of minor skin irritation and external itching due to rashes.

  • Warnings

    • For External Use Only

    • When using this product

    do not get into eyes.

    • Stop use and ask a doctor

    if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again in a few days.

    • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply to irritated and chafed skin as often as needed for instant relief.

  • Inactive Ingredients

    Water, Cetyl Ethylhexanoate, Glycerin, PEG-40 Hydrogenated Castor Oil, Glyceryl Dilaurate, Phenoxyethanol, Caprylyl Glycol, Sodium Polyacrylate, Dimethicone, Ceteareth-20, Glyceryl Oleate, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cyclopentasiloxane, Trideceth-6, Disodium EDTA, Sodium Hydroxide, PEG/PPG-18/18 Dimethicone, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract, Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL

    OMV! by Vagisil™ Bikini Anti-Itch Serum

    ~soothes bikini & intimate area

    with colloidal oatmeal

    ~pH balanced

    vanilla clementine

    Gynecologist Tested

    Net. Wt. 1.7oz (48 g)

    PRINCIPAL DISPLAY PANEL OMV! by Vagisil™ Bikini Anti-Itch Serum ~soothes bikini & intimate area with colloidal oatmeal ~pH balanced vanilla clementine Gynecologist Tested Net. Wt. 1.7oz (48 g)

  • INGREDIENTS AND APPEARANCE
    OMV ANTI-ITCH BIKINI 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-5282
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11509-5282-11 in 1 CARTON01/01/2020
    148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34701/01/2020
    Labeler - Combe Incorporated (002406502)
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