Label: CORETEX ANTI-ITCH GEL- camphor, diphenhydramine, zinc acetate gel

  • NDC Code(s): 65753-400-02, 65753-400-04, 65753-400-13, 65753-400-14
  • Packager: CoreTex Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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  • Active Ingredients

    Camphor 0.1%

    Diphenhydramine hydrochloride 2%

    Zinc acetate 1%

  • Purpose

    Extrenal analgesic

    External analgesic

    Skin protectant

  • Uses

    • For the temporary relief of itching and pain associated with minor cuts, minor skin irritations and rashes due to insect bites, poison ivy, poison oak, and poison sumac.
  • Warnings

    For external use only.

    Do Not Use

    • on chicken pox, blisters or on extensive areas of the skin
    • with any drugs containing diphenhydramine while using this product.
    • Avoid contact with the eyes
    • more than directed

    When using the product:

    • Keep out of eyes.

    Stop use and ask a doctor if

    • conditions worsen 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 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: do not use, consult a doctor.

  • Other Information

    • protect this product from excessive heat and direct sun.
  • Inactive Ingredients

    citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, SD alcohol 40, sodium citrate, water (aqua).

  • Questions?

    Call: (877) 684-5774

  • SPL UNCLASSIFIED SECTION

    Made in USA for CoreTex Products, Inc. Erwin, TN 37650 (877) 684-5774

  • PRINCIPAL DISPLAY PANEL 65753-400-02

    400-02

  • Principal Display Panel 65753-400-04

    400-04

  • Principal Display Panel 65753-13 and -14

    400-1314

  • INGREDIENTS AND APPEARANCE
    CORETEX ANTI-ITCH GEL 
    camphor, diphenhydramine, zinc acetate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL 1-ALLYL ETHER (UNII: QRB8092KPK)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65753-400-04177 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2019
    2NDC:65753-400-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product11/26/2019
    3NDC:65753-400-1325 in 1 CONTAINER11/26/2019
    31 mL in 1 POUCH; Type 0: Not a Combination Product
    4NDC:65753-400-14300 in 1 CONTAINER11/26/2019
    41 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/25/2019
    Labeler - CoreTex Products Inc (061944620)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises017701475manufacture(65753-400)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoreTex Products Inc061944620pack(65753-400)
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