Boudreauxs Ointment
FDA Label NDC 0132-0324

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by C.b. Fleet Company, Inc. for the product Boudreauxs (NDC 0132-0324). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc oxide, 16% 

Purpose

Skin protectant

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

avoid contact with the eyes

Stop Use And Ask A Doctor If

condition worsens or does not improve after 7 days

Keep Out Of Reach Of Children

If swallowed, seek medical help or call poison control center (1-800-222-1222)

Directions

  • Change wet and soiled diaper immediately
  • Cleanse the diaper area and allow to dry
  • Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime

Other Information

  • Store at 15-25⁰ C (59-77⁰ F)
  • Remove foil seal from tube’s tip before use
  • For use with infants, children and adults
  • Will stain clothing and fabric

Inactive Ingredients

mineral oil, paraffin, petrolatum, ricinus communis (castor) seed oil

Dist by C. B. Fleet Company, Inc.
Tarrytown, NY 10591
A Prestige Consumer Healthcare company
© 2019 Trade dress is owned by C.B. Fleet company Inc. 
All rights reserved. Made in USA

Principal Display Panel

Sensitive Skin

Boudreaux’s® Butt Paste

Diaper rash ointment

Skin protectant (16% zinc oxide)

NET WT. 4 OZ (113 g)

Sensitive Skinboudreaux’s® Butt Pastediaper Rash Ointmentskin Protectant (16% Zinc Oxide)net Wt. 4 Oz (113 G) (Boudreauxs Sensitive 01)

Sensitive Skinboudreaux’s® Butt Pastediaper Rash Ointmentskin Protectant (16% Zinc Oxide)net Wt. 4 Oz (113 G) (Boudreauxs Sensitive 01)

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