Label: CHIGGEREX- benzocaine cream

  • 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 January 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzocaine 10.0%

  • Purpose

    Pain Relief

  • Uses

    temporary relief of pain and itching due to

    • chigger bites
    • red bug bites
    • ticks
    • mosquito bites
  • Warnings

    For external use only.

    When using this product

    • avoid contact with the 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 within a few days.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Ask a doctor.

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Ascorbic Acid, Camphor, Chamomilla Recutita (Matricaria) Flower Extract, Cholecalciferol, Diazolidinyl Urea, Disodium EDTA, Eugenia Caryophyllus (Clove) Flower Oil, Fragrance,Mentha Piperita (Peppermint) Oil, Methylparaben, Octyldodecanol, Olea Europaea (Olive) Fruit Extract, PEG-2 Stearate, PEG-2 Stearate SE, PEG-8 Dimethicone, Propylene Glycol, Propylparaben, Pyridoxine HCl, Retinyl Palmitate, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Tocopheryl Acetate, Water, Zea Mays (Corn) Oil

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Randob Labs, Ltd.
    Box 440, Cornwall, NY 12518

  • PRINCIPAL DISPLAY PANEL - 50 g Jar Label

    THE ORIGINAL

    Chiggerex®
    2X Power!
    with 10% Benzocaine
    MEDICATED OINTMENT

    FOR CHIGGER, TICK
    AND ALL BUG BITES

    FAST, SOOTHING RELIEF
    With ALOE VERA
    Plus CHAMOMILE

    NET WT. 1.75 OZ. (50g)

    PRINCIPAL DISPLAY PANEL - 50 g Jar Label
  • INGREDIENTS AND APPEARANCE
    CHIGGEREX 
    benzocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMPHOR, (-)- (UNII: 213N3S8275)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Cholecalciferol (UNII: 1C6V77QF41)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CLOVE OIL (UNII: 578389D6D0)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Octyldodecanol (UNII: 461N1O614Y)  
    BLACK OLIVE (UNII: 2M6QWV94OC)  
    PEG-2 Stearate (UNII: 94YQ11Y95F)  
    PEG-8 Dimethicone (UNII: GIA7T764OD)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Sodium Propoxyhydroxypropyl Thiosulfate Silica (UNII: 208G222332)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Water (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    ColorYELLOW (Off-White to Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-350-5050 g in 1 JAR; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2020
    Labeler - Randob Labs,Ltd. (061995007)
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