Zinc Oxide Ointment

Zinc Oxide Ointment

Drug Labeling and Warnings

Drug Details

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ZINC OXIDE- zinc oxide ointment 
Galentic Pharma (India) Private Limited

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.

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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)

Principal Display Panel - 28 g Tube Carton
ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50382-051
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
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
Chlorocresol (UNII: 36W53O7109)  
Mineral Oil (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50382-051-131 in 1 CARTON04/04/2013
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 50382-051-141 in 1 CARTON04/04/2013
256 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 50382-051-2012 in 1 CASE04/04/2013
3425 g in 1 JAR; Type 0: Not a Combination Product
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/FEIBusiness Operations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-051) , MANUFACTURE(50382-051) , PACK(50382-051) , REPACK(50382-051) , STERILIZE(50382-051)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-051) , MANUFACTURE(50382-051) , PACK(50382-051) , REPACK(50382-051) , STERILIZE(50382-051)

Revised: 12/2017
 
Galentic Pharma (India) Private Limited


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