Label: ZINC OXIDE 20% ointment

  • 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 July 5, 2022

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

View All Sections
  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Skin protectant

  • Uses

    Skin Protectant

    • Helps treat and prevent diaper rash
    • Dries the ozzing and weeping of poison: •Ivy •Oak •Sumac
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help

  • Directions

    • For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply paste liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
    • For poison ivy, oak, and sumac: Apply as needed
  • Other Information

    • Store at room temperature
    • Avoid excessive heat and humidity
  • Inactive ingredients

    Cetomacrogol 1000, Cetostearyl alcohol, Mineral oil, Petrolatum

  • PRINCIPAL DISPLAY PANEL

    Questions of comments? Call 1-866-747-7365

    Manufactured for : SOLA Pharmaceuticals

    Baton Rouge, LA 70810


    Store at room temperature. Avoid excessive heat and humidity.

    Zinc Oxide 20% Ointment

    NDC 70512-103-30


    Qty: 28.4g

    Zinc Carton

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 20% 
    zinc oxide 20% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70512-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70512-103-301 in 1 CARTON04/22/2021
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/22/2021
    Labeler - SOLA Pharmaceuticals (080121345)
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!