LEADER ZINC OXIDE- zinc oxide ointment

Leader Zinc Oxide by

Drug Labeling and Warnings

Leader Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
• dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only

When using this product, avoid contact with the eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days to clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

• apply liberally as often as necessary

For Diaper Rash

• change wet or soiled diapers promptly
• cleanse the diaper area and allow to dry
• apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

For Poison Ivy, poison oak and poison sumac;

• cleanse the affect area and pat dry 
• apply ointment liberally, as often as necessary, using a cotton ball, sterile swab or gauze
• wash hands after use.

Inactive ingredients

mineral oil, petrolatum

Questions or comments?

Call 1-800-222-1087

Store at room temperature 20 - 25°C (68° - 77°F).

Principal Display Panel – Jar Label

Leader®       NDC: 70000-0334-1

Zinc Oxide

Ointment USP

Multi Purpose Skin Protectant 

provides soothing relief from poison ivy,

oak and sumac

Treats and prevents diaper rash

Net Wt 1 lb (454 g)

INGREDIENTS AND APPEARANCE

LEADER ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0334
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
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0334-1	454 g in 1 JAR; Type 0: Not a Combination Product	03/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/29/2019

Labeler - Cardinal Health LLC (097537435)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(70000-0334)