Boudreauxs Cream
FDA Label NDC 0132-0333

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 0132-0333). 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, uses, warnings, otc - stop use, otc - ask doctor, otc - keep out of reach of children, directions for use, other information, 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%, Skin Protectant

Uses

  • Helps treat and prevent diaper rash
  • Protests chafed skin due to diapter rash and helps seal out wetness

Warnings

  • For external use only
  • When using this product avoid contact with the eyes

Otc - Stop Use

Otc - Ask Doctor

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

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children to prevent accidental ingestion
  • If swallowed, seek medical help or call Poison Control Center immediately

Directions For Use

  • Change wet and soiled diapers 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 room temperature, 15C to 30C (59F to 86F)
  • Remove foil seal from the tube's tip or from jar
  • Use with infants, children and adults
  • Will stain clothing and fabric

Inactive Ingredients

Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, White Petrolatum

Questions Or Comments

Phone 1-855-785-2888 website www.buttpaste.com

Package Label.Principal Display Panel

Boudreauxs Butt Paste Original Carton 4 Oz (Bbporiginal4ozcarton)

Boudreauxs Butt Paste Original Carton 4 Oz (Bbporiginal4ozcarton)

Boudreauxs Butt Paste Original Carton 2 Oz (Bbporiginal2ozcarton)

Boudreauxs Butt Paste Original Carton 2 Oz (Bbporiginal2ozcarton)

Boudreauxs Butt Paste Original Jar (Bbporiginal16ozjar)

Boudreauxs Butt Paste Original Jar (Bbporiginal16ozjar)

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