LEADER DIAPER RASH- zinc oxide ointment

LEADER DIAPER RASH by

Drug Labeling and Warnings

LEADER DIAPER RASH by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                                       Purpose

Zinc oxide, 40% .....................................................................Skin protectant

PURPOSE

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps protect skin from wetness

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

over deep or puncture wounds, infections or lacerations

WHEN USING

When using this product avoid contact with the eyes

STOP USE

Stop use and ask a doctor if condition worsens or does not improve within 7 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.

INDICATIONS & USAGE

Directions

• change wet and soiled diapers promptly, cleanse the diaper area, and 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

STORAGE AND HANDLING

Other information

• store at 20o to 25oC (68o to 77oF)
• Lot No. and Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

butylhydroxyanisole, lavendar oil, liquid paraffin, methylparaben, polysorbate 60, purified lanolin, sorbitan monostearate, squalane, talc, tocopherol acetate, water, white petrolatum

DOSAGE & ADMINISTRATION

Distributed By Cardinal Health

Dublin, Ohio 43017

www.myleader.com

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER DIAPER RASH 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-637
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.40 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
LANOLIN (UNII: 7EV65EAW6H)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SQUALANE (UNII: GW89575KF9)
TALC (UNII: 7SEV7J4R1U)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-637-26	1 in 1 CARTON	10/11/2016
1		113 g in 1 TUBE; 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	01/20/2012

Labeler - CARDINAL HEALTH (097537435)