Cool

Cool
SPL v2
SPL
SPL Set ID 38fcc371-0eab-46e1-a98a-3784e12aa9af
Route
TOPICAL
Published
Effective Date 2010-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (0.57 g)
Inactive Ingredients
Water Mineral Oil Petrolatum Sorbitol Sorbitan Sesquioleate Lanolin Alcohols Phenoxyethanol Magnesium Hydroxide Ethylhexylglycerin Butylated Hydroxytoluene

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-04-25
Description

Drug Facts

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if:

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days
Warnings

For external use only

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.
Questions?

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

Active Ingredient

Dimethicone 1%

Inactive Ingredients

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

When Using This Product
  • Keep out of eyes.

    Rinse eyes thoroughly with water to remove.
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)

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days
Purpose

Skin protectant

Warnings

For external use only

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.
Questions?

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

Active Ingredient

Dimethicone 1%

Inactive Ingredients

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

When Using This Product
  • Keep out of eyes.

    Rinse eyes thoroughly with water to remove.
Principal Display Panel 57g Jar Carton (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:12.097164 · Updated: 2026-03-14T22:52:34.752454