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Zinc Oxide by Kinray Inc.

Medically reviewed on April 25, 2018

Dosage form: ointment
Ingredients: ZINC OXIDE 200mg in 1g
Labeler: Kinray Inc.
NDC Code: 63777-222

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

Purpose

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

Warnings:

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.

Inactive Ingredient 

Inactive ingredients: Light mineral oil, white petrolatum

Dosage and Administration

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

Indications and Usage
  • do not use if seal is punctured or if not visible
  • avoid excessive heat
  • store at room temperature 15 deg to 30 deg C, 59 deg F to 86 deg F

Principal Display Panel

Zinc Oxide Ointment

zinc_oxide_ointment.jpg

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-222
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:63777-222-0372 TUBE (TUBE) in 1 CASE
128.34 g in 1 TUBE
2NDC:63777-222-0172 TUBE (TUBE) in 1 CASE
256.68 g in 1 TUBE
3NDC:63777-222-0212 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 finalpart34704/19/2010
Labeler - Kinray Inc. (012574513)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIOperations
Galentic Pharma India Private Limited918531450manufacture(63777-222)
Establishment
NameAddressID/FEIOperations
Blossom Pharmaceuticals677381470manufacture(63777-222)

 
Kinray Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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