Boudreauxs Butt Barrier Ointment
FDA Label NDC 0132-0326

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 Butt Barrier (NDC 0132-0326). 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

Dimethicone, 1%

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

To prevent accidental ingestion. If swallowed, seek medical help or call poison control center (1-800-222-1222) immediately.

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 15-25° C (59-77° F)
  • Remove seal from jar before use
  • For use with infants, children and adults

Inactive Ingredients

Alpha-tocopherol acetate d- (Vitamin E acetate), castor seed oil, glyceryl hydroxystearate, and hydrogenated castor oil

Questions

1-855-785-2888

www. buttpaste.com

Principal Display Panel

Boudreaux’s Butt Paste®
Butt Barrier
Protective Ointment
Skin protectant / Dimethicone 1%

NET WT. 4 oz (113 g)                  

Boudreaux’s Butt Paste®butt Barrierprotective Ointmentskin Protectant / Dimethicone 1%net Wt. 4 Oz (113 G) (Boudreauxs Butt Barrier Ointment Dimethicone 0132 01)

Boudreaux’s Butt Paste®butt Barrierprotective Ointmentskin Protectant / Dimethicone 1%net Wt. 4 Oz (113 G) (Boudreauxs Butt Barrier Ointment Dimethicone 0132 01)

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