Label: TECNU CALAGEL- diphenhydramine hydrochloride gel

  • NDC Code(s): 51879-802-06, 51879-802-16, 51879-802-44, 51879-802-66
  • Packager: Tec Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Diphenhydramine HCL 2%

  • PURPOSE

    Purpose Topical analgesic / antihistamine

  • INDICATIONS & USAGE

    for temporary relief of pain and itching associated with:

    •minor burns •sunburn •minor cuts •scrapes •insect bites

    •minor skin irritations

    rashes due to: •poison oak •poison ivy •poison sumac

  • WARNINGS

    DO NOT USE:

    •if allergic to sulfites •on children under 2 years of age unless directed by a doctor

    •with any other products containing diphenydramine, even one taken by mouth

    •on deep puncture wounds, animal bites or serious burns unless directed by a doctor

    •on large areas of the body

  • ASK DOCTOR

    •on chicken pox •on measles

  • KEEP OUT OF REACH OF CHILDREN

    When using this product:

    •KEEP OUT OF REACH OF CHILDREN

    •if swallowed, get medical help or contact a poison control center right away

    •avoid contact with eyes

  • STOP USE

    Stop use and ask a doctor if: •condition worsens

    •symptoms persist for more than 7 days or clear up and occur again within a few days

  • DOSAGE & ADMINISTRATION

    Directions •do not use more often than directed

    •adults and children 2 years of age and older

    •cleanse skin with soap and warm water and dry affected area

    •apply to affected area not more than 3 times daily

    •may be covered with a sterile bandage, if bandaged, let dry first

    •children under 2 years of age do not use, consult a doctor

  • STORAGE AND HANDLING

    Other Information Store at 59 to 86ºF (15 to 30ºC)

  • INACTIVE INGREDIENT

    benzethonium chloride, disodium EDTA, fragrance, hypromellose,

    menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate

  • QUESTIONS

    Questions? Call 1-800-482-4464

    serious side effects may be reported to this number.

  • PRINCIPAL DISPLAY PANEL

    Calagel

  • PRINCIPAL DISPLAY PANEL

    Calagel POP

  • PRINCIPAL DISPLAY PANEL

    Calagel Dispenser

  • INGREDIENTS AND APPEARANCE
    TECNU CALAGEL 
    diphenhydramine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51879-802
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ZINC ACETATE (UNII: FM5526K07A)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    WATER (UNII: 059QF0KO0R)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51879-802-061 in 1 CARTON06/20/2019
    1NDC:51879-802-66178.9 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:51879-802-66178.9 g in 1 BOTTLE; Type 0: Not a Combination Product06/20/2019
    3NDC:51879-802-44144 in 1 CARTON07/23/2019
    3NDC:51879-802-161.86 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/20/2019
    Labeler - Tec Laboratories Inc. (083647792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tec Laboratories Inc.083647792manufacture(51879-802)