WALGREEN MAXIMUM STRENGTH DIAPER RASH - zinc oxide ointment 
WALGREEN COMPANY

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.

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DRUG FACTS


Active ingredient                            Purpose


Zinc Oxide. 40%.......................................Skin protectant


Uses

- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and helps seal out wetness


Keep out of the reach of children.
If swallowed, get medical help or contact
a Poison Control Center right away.


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 the 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
- 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

Other information

Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)


Inactive Ingredients

petrolatum, lanolin, cod liver oil (contains vitamin A and vitamin D),
purified water, talcum, methylparaben, fragrance, butylated hydroxyanisole


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WALGREEN MAXIMUM STRENGTH DIAPER RASH 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE400 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
WATER (UNII: 059QF0KO0R)  
TALC (UNII: 7SEV7J4R1U)  
COD LIVER OIL (UNII: BBL281NWFG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0402-521 in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2011
Labeler - WALGREEN COMPANY (008965063)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2011
Document Id: 64e1ba10-f315-47f9-ae64-1d47d6e5a241
Set id: a56d9cc7-9118-4bfa-8e66-6275a8570d96
Version: 2
Effective Time: 20110701
 
WALGREEN COMPANY