BABY BUTZ - starch, corn, lanolin and zinc oxide cream 
Olen Cosmetics Corporation

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.

----------

Drug Facts


Active Ingredients

Corn Starch 25%

Lanolin 15.5%

Zinc Oxide 30%

Purpose

Skin Protectant

Skin Protectant

Skin Protectant

Use

  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash
  • Helps seal out wetness

Warnings

For External Use Only

If condition worsen or does not improve within 7 days, consult a physician.

When Using this Product

Avoid Contact with eyes.

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

Directions

Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally as often as necessary with each diaper change especially at bedtime or any time exposure to wet diaper my be prolonged.

Other Information

Store between 15-30 degrees

Inactive Ingredients

Petrolatum

Questions?

1-877-494-4313

Principal Display Panel

Baby Butz Cream

30% Zinc Oxide Cream

Relieves + Prevents Diaper Rash

All Natural Ingredients

Earth-friendly

Olen Cosmetics Corporation

MB, Canada R2E 0M5

babybutz.com


Product Label

BABY BUTZ 
corn starch, lanolin, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52358-0000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STARCH, CORN (STARCH, CORN) STARCH, CORN14.3 g  in 57 g
LANOLIN (LANOLIN) LANOLIN8.8 g  in 57 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE17.1 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:52358-0000-157 g in 1 JAR
2NDC:52358-0000-2113 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34707/17/2012
Labeler - Olen Cosmetics Corporation (250916611)

Revised: 07/2012
Document Id: e43f95d0-1d69-460e-8603-804ed75e72d9
Set id: d2ad2755-19d7-4da4-b28a-5423439d4f98
Version: 1
Effective Time: 20120717
 
Olen Cosmetics Corporation