Label: MONISTAT CARE INSTANT ITCH RELIEF- benzocaine spray

  • NDC Code(s): 63736-050-01
  • Packager: Insight Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 11, 2017

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  • SPL UNCLASSIFIED SECTION

    Monistat Care – Benzocaine 20% / Topical analgesic

    PDP

    Monistat Care

    20 % Benzocaine / Topical analgesic

    Instant Itch Relief Spray

    NET WT. 2 OZ (57 g)

    Drug Facts

  • Active ingredient 

    Benzocaine 20%

  • Purpose  

    Topical analgesic

  • Uses 

    Temporary relief of pain and itching

  • Warnings

    For external use only

    Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

    Contents under pressure. Do not puncture or incinerate. Flammable mixture; do not use near fire or flame, or expose to heat or temperatures above 49°C (120°F). Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    • condition worsens, or symptoms persists for more than 7 days
    • symptoms 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

    • shake can well, hold 8" to 12" from affected area; spray liberally.
    • adults and children 12 years and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years: consult a physician
  • Other information

    Store at room temperature 15°– 25°C (59°– 77°F).

  • Inactive ingredients 

    Polyethylene glycol 300 
    Propellant: Isobutane, normal butane, propane

  • Questions? 

    Call toll free 1-877-666-4782

  • PRINCIPAL DISPLAY PANEL

    MONISTAT
    Care
    20% Benzocaine/ Tropical Analgesic
    MAXIMUM STRENGTH
    INSTANT
    Itch Relief
    SPRAY
    Net WT.2 OZ(57g)

    PRINCIPAL DISPLAY PANEL INTENSE ITCH RELIEF MONISTAT Care 20% Benzocaine/ Tropical Analgesic MAXIMUM STRENGTH INSTANT Itch Relief SPRAY Net WT.2 OZ(57g)

  • INGREDIENTS AND APPEARANCE
    MONISTAT CARE INSTANT ITCH RELIEF 
    benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE11.4 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-050-0157 g in 1 CAN; Type 0: Not a Combination Product10/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/01/2017
    Labeler - Insight Pharmaceuticals LLC (055665422)
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