Label: BITEMD EXTERNAL ANALGESIC FIRST AID ANTISEPTIC (benzocaine, camphor- synthetic, and phenol liquid

  • NDC Code(s): 79364-0932-1
  • Packager: United Industries Corporation
  • 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 August 10, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active Ingredients:Purpose:
    Benzocaine 5%Analgesic, Anesthetic, Antipruritic
    Camphor 3%Topical Analgesic
    Phenol 1.35%First Aid Antiseptic
  • Uses

    First aid for temporary relief of:

    • Pain
    • Itching
    • Infection
  • Warnings

    For external use only

    When using this product

    • Do not get in eyes.
    • Do not apply over large areas of the body or bandage.
    • In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.

    Stop use and ask doctor if condition worsens; or if symptoms persist for more than 7 days, clear up and occur again within a few days. Do not use longer than one week unless directed by doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If in eyes, flush with water for 15 minutes and call a physician.

  • Directions

    • Clean area.
    • Apply to the bite area by pressing straight down repeatedly until liquid flows, then dab sparingly.
    • If itching persists, apply again in 10 to 15 minutes.
    • For ticks and bees, remove tick or stinger before treatment.
  • Other Information

    • Store at room temperature.
  • Adult and children 2 years and over

    Apply to affected area 1 to 3 times daily

  • Children under 2 years

    Consult a doctor

  • Inactive Ingredients

    Propylene Glycol

  • Questions or Comments?

    Call 1-800-767-9927.

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    Wisconsin Pharmacal Company, LLC
    Jackson, WI 53037 USA
    Distributed by Spectrum
    Division of United Industries Corporation
    PO Box 142642, St. Louis, MO 63114-0642

  • PRINCIPAL DISPLAY PANEL - 14.7 mL Bottle Label

    BiteMD®

    External Analgesic
    First Aid Antiseptic

    from the makers of
    Cutter®
    BRAND

    INSECT
    BITE RELIEF

    ✓
    STOPS PAIN
    ✓
    RELIEVES ITCHING
    ✓
    REDUCES INFECTION

    Chiggers
    Wasps
    Mosquitoes
    Ticks

    Soft Tip For
    Controlled Application

    Net 0.5 fl oz (14.7 mL)

    PRINCIPAL DISPLAY PANEL - 14.7 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BITEMD EXTERNAL ANALGESIC FIRST AID ANTISEPTIC 
    benzocaine, camphor (synthetic), and phenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79364-0932
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine0.0524 mg  in 1 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.03144 mg  in 1 mL
    Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol0.01572 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79364-0932-114.7 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2020
    Labeler - United Industries Corporation (068527704)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal800873986MANUFACTURE(79364-0932)
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