Label: THERACARE EXTRA STRENGTH ANTI-ITCH CREAM ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate 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 February 24, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Diphenhydramine hydrochloride 2%Topical analgesic
    Zinc acetate 0.1%Skin protectant
  • Uses

    • temporarily relieves pain and itching associated with:
      • insect bites
      • minor burns
      • sunburn
      • minor skin irritations
      • minor cuts
      • scrapes
      • minor skin irritations
      • rashes due to poison ivy, poison oak, oak, and sumac
    • dries the oozing and weeping of poison ivy, poison oak, and poison sumac
  • Warnings

    For external use only

    Do not use

    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth

    Ask a doctor before use

    • on chicken pox
    • on measles

    When using this product

    • use only as directed
    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • 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. (1-800-222-1222)

  • Directions

    • adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a physician
  • Other information

    • store at 20°C-25°C (68°C/77°F)
    • do not use if tube seal under cap is broken
  • Inactive ingredients

    cetyl alcohol, di sodium edetate, Diazolidinyl urea, methylparaben, peg-100 stearate, peg-2 stearate, petrolatum, potassium hydroxide, polyethylene glycol, propylparaben, stearic acid, water

  • Questions?

    toll-free 866-326-1313

  • TheraCare Extra Strength Anti-Itch Cream

    labelPack

  • INGREDIENTS AND APPEARANCE
    THERACARE EXTRA STRENGTH ANTI-ITCH CREAM   ITCH STOPPING
    diphenhydramine hydrochloride and zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG-2 STEARATE (UNII: 94YQ11Y95F)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-215-011 in 1 CARTON09/01/2021
    135.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2021
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-215)
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