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Flanders Buttocks

Dosage form: ointment
Ingredients: PETROLATUM 66.2g in 100g, ZINC OXIDE 13.4g in 100g
Labeler: Flanders Inc
NDC Code: 54323-215

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.

Active Ingredients

White Petrolatum 66.2%....................Skin Protectant

Zinc Oxide 13.4%..............................Skin Protectant

Uses
  • Helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect from wetness

Directions
  • change wet and soiled diapers promptly, cleanse the diaper area, allow to dry
  • apply ointment liberally as necessary, with each diaper change, especailly at bedtime or anytime prolonged exposure to wet diapers may be prolonged

Keep out of reach of children

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

Warnings

For External Use only

Do not Useover deep puncture wounds, infections, or lacerations.

When using this product avoid contact with eyes.

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Inactive Ingredients

castor oil, light mineral oil, peruvian balsam, white beeswax

Purpose

Skin Protectant

Other Information
  • store at room temperature
  • Lot No. and Exp Date: see crimp of tube
  • may stain clothing

Questions or Comments

Call 1-855-NIX-RASH (1-855-649-7472)

Tube image

FLANDERS BUTTOCKS 
white petrolatum, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54323-215
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM66.2 g  in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE13.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WHITE WAX 
CASTOR OIL 
BALSAM PERU 
LIGHT MINERAL OIL 
Product Characteristics
Colorbrown (light brown, thick ointment) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54323-215-02113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/16/1986
Labeler - Flanders Inc (807921564)
Establishment
NameAddressID/FEIOperations
L. PERRIGO COMPANY006013346manufacture(54323-215)

Revised: 05/2016
 
Flanders Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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