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Zinc Oxide by Galentic Pharma (India) Priva Te Limited

Dosage form: ointment
Ingredients: ZINC OXIDE 200mg in 1g
Labeler: Galentic Pharma (India) Priva Te Limited
NDC Code: 50382-051

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.

Zinc Oxide Ointment

Section Text

Active Ingredient                            Purpose

Zinc Oxide (200mg in each gram)   Skin Protectant


  • Helps treat and prevent diaper rash.
  • Dries the oozing and weeping of;
  • poison ivy
  • poison oak
  • poison sumac


For External Use Only

When using this product:
  • Do not get in eyes.

Stop use and ask a doctor if:
  • conditions worsens
  • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician.
  • over large areas of the body
  • if you are allergic to any of these ingredients

Do not use on:
  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


For diaper rash:

  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

For poison ivy, poison oak, poison sumac:

  • apply liberally as often as needed

Inactive Ingredients

Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White Soft Paraffin

Principal Display


zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-051
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:50382-051-0372 TUBE (TUBE) in 1 CASE
128.34 g in 1 TUBE
2NDC:50382-051-0172 TUBE (TUBE) in 1 CASE
256.68 g in 1 TUBE
3NDC:50382-051-0212 JAR (JAR) in 1 CASE
3425.1 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/19/2013
Labeler - Galentic Pharma (India) Priva Te Limited (918531450)
Galentic Pharma (India) Priva Te Limited918531450manufacture(50382-051)

Revised: 07/2013
Galentic Pharma (India) Priva Te Limited

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.