Label: ASSURED CALAMINE- calamine 8% and zinc oxide 8% lotion

  • NDC Code(s): 33992-4130-6
  • Packager: Greenbriar International
  • Category: HUMAN OTC DRUG LABEL

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 March 17, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Calamine 8% and Zinc Oxide 8%

  • Purpose

    Skin protectant

  • Uses

    Dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

  • Warnings

    For external use only. Use only as directed.

    Avoid contact with eyes and mucous membranes.

    Ask a doctor before using on chilren 6 months of age.

  • When using this product

    Discontinue use if condition worsens or does not improve within 7 days and consult a doctor.

  • Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

  • Directions

    Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.

    Children under 6 months of age: Consult a doctor before use.

  • Other information

    Store at room temperature 13-30C (50-86F)

  • Inactive ingredients

    Bentonite magma, calcium hydroxide, glycerin, purified water.

  • assured calamine

    assured calamine.jpg

  • INGREDIENTS AND APPEARANCE
    ASSURED CALAMINE 
    calamine 8% and zinc oxide 8% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-4130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-4130-6177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/27/2020
    Labeler - Greenbriar International (610322518)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114label(33992-4130) , manufacture(33992-4130) , analysis(33992-4130) , pack(33992-4130)
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

More Info on this Drug

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