LEADER DIAPER RASH CREAM- diaper rash cream cream 
Cardinal Health

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.

----------

CR-1189

Active Ingredient

Zinc Oxide 40%

Purpose

Skin Protectant

Uses

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

Other Information

Inactive Ingredients

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

Questions?

1-888-DYNAREX

Label

CR1189LABEL

LEADER DIAPER RASH CREAM 
diaper rash cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-981
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-981-131 in 1 BOX08/03/2018
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/03/2018
Labeler - Cardinal Health (097537435)

Revised: 8/2018
Document Id: 72896ba2-9760-50ff-e053-2991aa0a6af8
Set id: 72896ba2-975f-50ff-e053-2991aa0a6af8
Version: 1
Effective Time: 20180803
 
Cardinal Health