Coolbottoms
FDA Label NDC 50952-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ph R&d Llc for the product Coolbottoms (NDC 50952-001). 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, directions, inactive ingredients, questions?, 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 diaper rash
  • temporarily protects and helps relieve chapped or cracked skin
  • protects chafed skin as associated with diaper rash and helps seal out wetness

Warnings

For external use only

When Using This Product

  • Keep out of eyes.
    Rinse eyes thoroughly with water to remove.

Directions

  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply cream liberally as often as necessary, especially at bedtime when exposure to wet diapers may be prolonged.

Inactive Ingredients

Water, Mineral Oil, White Petrolatum, Sorbitol, Ceresine, Sorbitan Sesquioleate, Lanolin Alcohol, Phenoxyethanol, Magnesium Hydroxide, Ethylhexylglycerin, BHT

Questions?

M-F CST Call: 1-877-725-RASH

Principal Display Panel - 57G Jar Carton

developed by a
pediatrician

PATENTED
Cool
bottoms®
DIAPER RASH CREAM
skin protectant
cools and soothes

NET WT 2 OZ (57g)

Principal Display Panel (57g jar carton)

Principal Display Panel (57g jar carton)

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