Label: CALAMINE- calamine, pramoxind hcl lotion

  • NDC Code(s): 41163-009-30
  • Packager: United Natural Foods, Inc. dba UNFI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 15, 2023

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

View All Sections
  • Active ingredients

    Calamine 8%

    Pramoxind HCl 1%

  • Purpose

    Skin protectant

    External analgesic

  • Use

    • for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac
    • dries the oozing and weeping of poison:
    • ivy
    • oak
    • sumac
  • Warnings

    For external use only

  • When using this product

    • do not get into eyes
  • Stop use and ask a doctor

    • condition worsens
    • symptoms last more than 7 days or clean 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

    • shake well
    • before applying was affected are of skin

    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, ask a doctor

  • Other information

    store at room temperature (59°-77°F)

  • Inactive ingredients

    alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol,
    Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

  • Dislcaimer

    This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company distributor of Caladryl Lotion

  • principal display panel

    Compare to Caladryl Lotion

    active ingredient

    NDC 41163-009-30

    EQUALINE

    medicated

    calamine

    lotion

    external analgesic

    skin protectant

    drying action

    plus itch relief

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    calamine, pramoxind hcl lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED8.6 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 mg  in 1 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    water (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-009-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/21/2009
    Labeler - United Natural Foods, Inc. dba UNFI (943556183)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41163-009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41163-009)
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!