Boudreauxs Baby Shower Bundle Kit
FDA Label NDC 0132-0327

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 Baby Shower Bundle (NDC 0132-0327). 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 purpose, uses, warnings, keep out of the reach of children., directions, other information, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

Zinc oxide, 40%...................................................Skin protectant

Dimethicone, 1% ...................................................Skin protectant

Uses

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

Warnings

For external use only

For external use only.

Keep Out Of The Reach Of Children.

If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately.

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
    • 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°C to 25°C (59°F to 77°F)
  • Remove foil seal prior to use
  • Use with infants, children and adults
  • Will stain clothing and fabric
    • Store at 15°C to 25°C (59°F to 77°F)
    • Remove foil seal from tube’s tip before use
    • For use with infants, children and adults

Inactive Ingredients

myroxylon pereiraie (balsam peru) resin, mineral oil, paraffin, petrolatum, ricinus communis (castor) seed oil

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

Questions Or Comments

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

BOUDREAUX’S BUTT PASTE ® Butt Barrier

Protective Ointment

SKIN PROTECTANT (DIMETHICONE)

Drug Facts

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

BOUDREAUX’S® BUTT BRUSH

DIAPER CREAM APPLICATOR

BPA FREE SILICONE

Instructions:

Step 1: Apply Butt Paste® on brush head.

Step 2: Gently brush Butt Paste® on baby’s bottom. For best results, apply thick coat to form a protective barrier.

Step 3: Clean after each use with a baby wipe. Brush can be disinfected in boiling water as needed. It is also dishwasher safe.

Suction cup sticks on almost any surface when changing the diaper.

WARNING:

The Boudreaux’s Butt Brush™ is not a toy. Use only as directed. Discontinue use if skin shows signs of sensitivity or irritation towards the Boudreaux’s Butt Brush™. Discard or sterilize the Boudreaux’s Butt Brush™ in boiling water if comes in contact with yeast infected skin or an infectious rash.

Principal Display Panel

BOUDREAUX’S® Baby Shower Bundle

KIT INCLUDES:

-Maximum Strength Boudreaux’s Butt Paste® -NET WT. 2oz (57 g)

-Maximum Strength Boudreaux’s Butt Paste®- NET WT. 14oz (396 g)

-Boudreaux’s Butt Paste Butt Barrier -NET WT. 4 oz (113 g)

-Boudreaux’s Butt Brush™

Principal Display Panelboudreaux’s® Baby Shower Bundlekit Includes: -maximum Strength Boudreaux’s Butt Paste® -net Wt. 2oz (57 G)-maximum Strength Boudreaux’s Butt Paste®- Net Wt. 14oz (396 G)-boudreaux’s Butt Paste Butt Barrier -net Wt. 4 Oz (113 G)-boudreaux’s Butt Brush™ (Boudreauxs Butt Paste Baby Shower Bundle 0132 0327 01)

Principal Display Panelboudreaux’s® Baby Shower Bundlekit Includes: -maximum Strength Boudreaux’s Butt Paste® -net Wt. 2oz (57 G)-maximum Strength Boudreaux’s Butt Paste®- Net Wt. 14oz (396 G)-boudreaux’s Butt Paste Butt Barrier -net Wt. 4 Oz (113 G)-boudreaux’s Butt Brush™ (Boudreauxs Butt Paste Baby Shower Bundle 0132 0327 01)

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