Label: TOPCARE CALAGESIC- calamine and pramoxine hydrochloride lotion lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Calamine 8%

    Pramoxine Hydochloride 1%

  • PURPOSE

    Skin Protectant

    External analgesic

  • INDICATIONS & USAGE

    Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.

  • WARNINGS

    For external use only. Use only as directed.

    When using this product. Avoid contact with eyes and moucous membranes.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

    Children under 2 yrs. of age. Consult a doctor before use.

  • INACTIVE INGREDIENT

    SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.

  • PRINCIPAL DISPLAY PANEL

    Top Care Calagesic 2022TCGesig.jpg

  • INGREDIENTS AND APPEARANCE
    TOPCARE CALAGESIC 
    calamine and pramoxine hydrochloride lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-268
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-268-96177 mL in 1 CONTAINER; Type 0: Not a Combination Product07/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/16/2019
    Labeler - TOPCO ASSOCIATES LLC (006935977)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(36800-268) , pack(36800-268) , label(36800-268) , manufacture(36800-268)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!