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]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Gandhidham-370 230, Gujarat. 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)

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)
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-051-13	1 in 1 CARTON	04/04/2013
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 50382-051-14	1 in 1 CARTON	04/04/2013
2		56 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 50382-051-20	12 in 1 CASE	04/04/2013
3		425 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/04/2013

Labeler - Galentic Pharma (India) Private Limited (915110464)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	analysis(50382-051) , manufacture(50382-051) , pack(50382-051) , repack(50382-051) , sterilize(50382-051)