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Zinc Oxide by Galentic Pharma (India) Private Limited

Medically reviewed on December 29, 2017

Dosage form: ointment
Ingredients: Zinc Oxide 200mg in 1g
Labeler: Galentic Pharma (India) Private 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

Drug Facts

• ACTIVE INGREDIENT

Zinc Oxide 20%

• PURPOSE

Skin Protectant

• USES

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash and helps seal out wetness

• WARNINGS

For external use only.

  • When using this product
    • do not get into 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 or contact a Poison Control Center right away.

• DOSAGE & ADMINISTRATION
  • Change wet and soiled diapers promptly
  • Cleanse the diaper area
  • Allow to dry
  • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

• OTHER INFORMATION
  • Store at 15° to 30° C (59° to 86° F)
  • Lot No. & Exp. Date: See box or crimp of tube

• INACTIVE INGREDIENT

Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,
Gandhidham-370 230, Gujrat. India

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Galentic

Zinc Oxide
Ointment
SKIN PROTECTANT

Helps Heal, Soothe &
Prevent Diaper Rash

NET WT.
1 OZ. (28g)

ZINC OXIDE 
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
Zinc Oxide (Zinc Oxide) Zinc Oxide200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Cetostearyl Alcohol 
CETETH-20 
Chlorocresol 
Mineral Oil 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:50382-051-131 TUBE in 1 CARTON
128 g in 1 TUBE
2NDC:50382-051-141 TUBE in 1 CARTON
256 g in 1 TUBE
3NDC:50382-051-2012 JAR in 1 CASE
3425 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34704/04/2013
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-051), MANUFACTURE(50382-051), PACK(50382-051), REPACK(50382-051), STERILIZE(50382-051)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-051), MANUFACTURE(50382-051), PACK(50382-051), REPACK(50382-051), STERILIZE(50382-051)

 
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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