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zinc oxide by Galentic Pharma (India) Private Limited

Medically reviewed on August 9, 2017

Dosage form: ointment
Ingredients: ZINC OXIDE 1.8g in 100g
Labeler: Galentic Pharma (India) Private Limited
NDC Code: 50382-011

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.

Galentic GalShield Ointment

Active Ingredient               Purpose

Zinc Oxide (1.8% w/w)      Skin Protectant

Uses:
  • Helps treat and prevent diaper rash
  • Temporarily protects
  • minor cuts
  • scrapes and
  • burns
  • 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:
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage and Administration:

For skin protectant:

  • Apply liberally as needed

For diaper Rash:

  • change wet and soiled diapers promptly
  • allow to dry
  • apply ointment liberally with each diaper change

Other information:
  • Store at room temperature
  • avoid excessive heat
  • contains color additives including FDC yellow # 5

Indications and Usage: For use as a general skin protectant and diaper rash.

Inactive Ingredients

Inactive ingredients:

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-10, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Trolamine, Vitamin A, Water


Principal Display Panel

Galentic GalShield

GalShield.jpg

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE1.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN 
CETETH-10 
MINERAL OIL 
PARAFFIN 
METHYLPARABEN 
PROPYLPARABEN SODIUM 
GLYCERIN 
PHENOXYETHANOL 
CETYL ALCOHOL 
STEARETH-20 
POLYETHYLENE GLYCOL 6000 
POLYSORBATE 60 
CETOSTEARYL ALCOHOL 
CHOLECALCIFEROL 
VITAMIN A 
ALPHA-TOCOPHEROL 
ALOE VERA LEAF 
PETROLATUM 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:50382-011-01114 g in 1 TUBE
2NDC:50382-011-02427.5 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/08/2013
Labeler - Galentic Pharma (India) Private Limited (918531450)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited918531450manufacture(50382-011)

 
Galentic Pharma (India) Private 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.

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