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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
Purpose

Skin protectant

Description

Drug Facts

Medication Information

Warnings

For external use only

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
Purpose

Skin protectant

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

Description

Drug Facts

Questions?

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

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
Active Ingredient

Dimethicone 1%

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

Warnings

For external use only

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
Purpose

Skin protectant

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

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
Active Ingredient

Dimethicone 1%

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