Zinc Oxide by Galentic Pharma (India) Priva Te 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) Priva Te Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Section Text

Active Ingredient                            Purpose

Zinc Oxide (200mg in each gram)   Skin Protectant

Uses:

• 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.

Directions:

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
  

Inactive Ingredients

Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White Soft Paraffin

Principal Display

Galzinc.jpg

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-051-03	72 in 1 CASE
1		28.34 g in 1 TUBE
2	NDC: 50382-051-01	72 in 1 CASE
2		56.68 g in 1 TUBE
3	NDC: 50382-051-02	12 in 1 CASE
3		425.1 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/19/2013

Labeler - Galentic Pharma (India) Priva Te Limited (918531450)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Priva Te Limited		918531450	manufacture(50382-051)