LEADER DIAPER RASH CREAM- diaper rash cream cream

Leader Diaper Rash Cream by

Drug Labeling and Warnings

Leader Diaper Rash Cream by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 40%

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• change wet and soiled diapers promptly
• cleanse the diaper area, and allow to dry
• apply paste 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 between 20° to 25°C (68° to 77°F)
• may stain clothing

Inactive Ingredients

white soft paraffine, COD liver oil, lanoline, talcum, glycerine, sorbitan soquioleate, beeswax, tocopheryl acetate, fragrance.

Questions?

1-888-DYNAREX

Label

INGREDIENTS AND APPEARANCE

LEADER DIAPER RASH CREAM 
diaper rash cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-981
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
COD LIVER OIL (UNII: BBL281NWFG)
LANOLIN (UNII: 7EV65EAW6H)
TALC (UNII: 7SEV7J4R1U)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
YELLOW WAX (UNII: 2ZA36H0S2V)
LIQUID PETROLEUM (UNII: 6ZAE7X688J)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-981-13	1 in 1 BOX	08/03/2018
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	08/03/2018

Labeler - Cardinal Health (097537435)