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

zinc oxide by

Drug Labeling and Warnings

zinc oxide by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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 & USAGE

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

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
CETETH-10 (UNII: LF9X1PN3XJ)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARETH-20 (UNII: L0Q8IK9E08)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
VITAMIN A (UNII: 81G40H8B0T)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PETROLATUM (UNII: 4T6H12BN9U)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-011-01	114 g in 1 TUBE
2	NDC: 50382-011-02	427.5 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/08/2013

Labeler - Galentic Pharma (India) Private Limited (918531450)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		918531450	manufacture(50382-011)