BABY BUTZ- 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.

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DRUG FACTS

Active Ingredients

Zinc Oxide 30%

Purpose

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

corn starch, lanolin, petrolatum

Questions?

1-877-494-4313

Principal Display Panel

Baby Butz

Cream

Relieves + Prevents

Diaper Rash

100% Natural

30% Zinc Oxide Cream

Earth-friendly

babybutz.com

Product Label

BABY BUTZ 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52358-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE17.1 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LANOLIN 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52358-0001-157 g in 1 JAR
2NDC:52358-0001-2113 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/15/2013
Labeler - Olen Cosmetics Corporation (250916611)

Revised: 7/2013
Document Id: 4364a9bc-4d12-4bde-ab5f-95ca962d6fef
Set id: e6be6b62-13a4-410d-b8ac-457b58fd23da
Version: 1
Effective Time: 20130715
 
Olen Cosmetics Corporation