Boudreauxs Cream
FDA Label NDC 0132-0334

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 0132-0334). 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, stop use and ask a doctor, keep out of the reach of children, directions for use, other information, inactive ingredients, 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
  • 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 The Reach Of Children

  • Keep out of the 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 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 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
  • Use with infants, children and adults

Inactive Ingredients

Aloe Vera, Beeswax, Carnauba Wax, Castor Oil, Citric Acid, Hydrogenated Castor Oil, Peruvian Balsam Oil

Questions Or Comments

Phone 1-855-785-2888

Package Label.Principal Display Panel

Boudreauxs Butt Paste Carton (Boudreauxsnaturalbuttpaste4ozcarton)

Boudreauxs Butt Paste Carton (Boudreauxsnaturalbuttpaste4ozcarton)

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