Zinc Oxide by Kinray Inc. / Dynarex Corporation / Galentic Pharma India Private Limited / Blossom Pharmaceuticals ZINC OXIDE ointment

Zinc Oxide by

Drug Labeling and Warnings

Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Kinray Inc., Dynarex Corporation, Galentic Pharma India Private Limited, Blossom Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Section Text

Active Ingredient                            Purpose

Zinc Oxide (200mg in each gram)   Skin Protectant

Purpose

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.

Inactive Ingredient 

Inactive ingredients: Light mineral oil, white petrolatum

Dosage and Administration

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
  

Indications and Usage

• do not use if seal is punctured or if not visible
• avoid excessive heat
• store at room temperature 15 deg to 30 deg C, 59 deg F to 86 deg F
  

Principal Display Panel

Zinc Oxide Ointment

zinc_oxide_ointment.jpg

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63777-222
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
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63777-222-03	72 in 1 CASE
1		28.34 g in 1 TUBE
2	NDC: 63777-222-01	72 in 1 CASE
2		56.68 g in 1 TUBE
3	NDC: 63777-222-02	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	04/19/2010

Labeler - Kinray Inc. (012574513)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma India Private Limited		918531450	manufacture(63777-222)

Establishment
Name	Address	ID/FEI	Business Operations
Blossom Pharmaceuticals		677381470	manufacture(63777-222)