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, 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)

Principal Display Panel - 28 g Tube Carton

ZINC OXIDE
zinc oxide ointment

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

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

Ingredient Name	Strength
Inactive Ingredients
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/04/2013

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

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

Revised: 11/2022

Document Id: ee828336-d292-2eb6-e053-2995a90ad9db

Set id: 45e1d7b2-934c-4de0-a16e-01ecd1c0619e

Version: 5

Effective Time: 20221128

Galentic Pharma (India) Private Limited