Cool bottoms ® DIAPER RASH CREAM

Manufacturer: pH R&D LLC
Effective date: 2010-11-19
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:26:55

Label at a glance#

ProductCoolbottoms Diaper Rash

Active ingredientDimethicone

Label structure10 sections

Indications and 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

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

When Using This Product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by
GinJen
Hammond, LA 70401

PRINCIPAL DISPLAY PANEL - 57g jar carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1044936	Cool bottoms 1 % Topical Cream	PSN	2
200010	dimethicone 1 % Topical Cream	PSN	2
1044936	dimethicone 10 MG/ML Topical Cream [Cool bottoms]	SBD	2
200010	dimethicone 10 MG/ML Topical Cream	SCD	2
1044936	Cool bottoms 1 % Topical Cream	SY	2
1044936	Cool bottoms 10 MG/ML Topical Cream	SY	2
200010	dimethicone 1 % Topical Cream	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50952-001-01	2019-10-29	C162847	48780-1	960f7f55-c5a2-8e05-e053-dbdaa90a074a	Cool bottoms ® DIAPER RASH CREAM
50952-001-02	2019-10-29	C162847	48780-1	960f7f55-c5a2-8e05-e053-dbdaa90a074a	Cool bottoms ® DIAPER RASH CREAM
50952-001-03	2019-10-29	C162847	48780-1	960f7f55-c5a2-8e05-e053-dbdaa90a074a	Cool bottoms ® DIAPER RASH CREAM
50952-001-04	2019-10-29	C162847	48780-1	960f7f55-c5a2-8e05-e053-dbdaa90a074a	Cool bottoms ® DIAPER RASH CREAM
50952-001-05	2019-10-29	C162847	48780-1	960f7f55-c5a2-8e05-e053-dbdaa90a074a	Cool bottoms ® DIAPER RASH CREAM
50952-001-06	2019-10-29	C162847	48780-1	960f7f55-c5a2-8e05-e053-dbdaa90a074a	Cool bottoms ® DIAPER RASH CREAM
50952-001-07	2019-10-29	C162847	48780-1	960f7f55-c5a2-8e05-e053-dbdaa90a074a	Cool bottoms ® DIAPER RASH CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50952-001-01	Coolbottoms Diaper Rash	57 g in 1 JAR	CREAM	57	2
50952-001-01	Coolbottoms Diaper Rash	1 in 1 BOX	CREAM	1	2
50952-001-02	Coolbottoms Diaper Rash	12 in 1 BOX	CREAM	12	2
50952-001-02	Coolbottoms Diaper Rash	57 g in 1 JAR	CREAM	57	2
50952-001-03	Coolbottoms Diaper Rash	24 in 1 BOX	CREAM	24	2
50952-001-03	Coolbottoms Diaper Rash	57 g in 1 JAR	CREAM	57	2
50952-001-04	Coolbottoms Diaper Rash	28 g in 1 JAR	CREAM	28	2
50952-001-04	Coolbottoms Diaper Rash	4 in 1 BOX	CREAM	4	2
50952-001-05	Coolbottoms Diaper Rash	8 in 1 BOX	CREAM	8	2
50952-001-05	Coolbottoms Diaper Rash	28 g in 1 JAR	CREAM	28	2
50952-001-06	Coolbottoms Diaper Rash	12 in 1 BOX	CREAM	12	2
50952-001-06	Coolbottoms Diaper Rash	28 g in 1 JAR	CREAM	28	2
50952-001-07	Coolbottoms Diaper Rash	28 g in 1 JAR	CREAM	28	2
50952-001-07	Coolbottoms Diaper Rash	24 in 1 BOX	CREAM	24	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50952-001	COOLBOTTOMS (DIMETHICONE) CREAM [PH R&D LLC]	2	Legacy NDC, 14 package rows	20110113_38fcc371-0eab-46e1-a98a-3784e12aa9af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50952-001-01	GM - Gram	50952-001	01ec3b6a-17b8-491e-ab60-4bdef3b4d457	1	2012-07-24
50952-001-02	GM - Gram	50952-001	9ad291b2-0dc4-431d-8df5-5ab86d4dbb42	1	2012-07-24
50952-001-03	GM - Gram	50952-001	34b1d14b-1ce2-4ace-98be-0ee4d8914f81	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	2
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	2
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	2
Ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	2
Lanolin Alcohols	INACTIVE INGREDIENT	884C3FA9HE	2
Magnesium Hydroxide	INACTIVE INGREDIENT	NBZ3QY004S	2
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	2
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	2
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	2
Sorbitan Sesquioleate	INACTIVE INGREDIENT	0W8RRI5W5A	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Coolbottoms Diaper Rash
Dimethicone
Water
Mineral Oil
Petrolatum
Sorbitol
Sorbitan Sesquioleate
Lanolin Alcohols
Phenoxyethanol
Magnesium Hydroxide
Ethylhexylglycerin
Butylated Hydroxytoluene

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50952-001	50952-001-04, 50952-001-05, 50952-001-06, 50952-001-07, 50952-001-01, 50952-001-02, 50952-001-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Dimethicone	92RU3N3Y1O	ACTIB
Water	059QF0KO0R	IACT
Mineral Oil	T5L8T28FGP	IACT
Petrolatum	4T6H12BN9U	IACT
Sorbitol	506T60A25R	IACT
Sorbitan Sesquioleate	0W8RRI5W5A	IACT
Lanolin Alcohols	884C3FA9HE	IACT
Phenoxyethanol	HIE492ZZ3T	IACT
Magnesium Hydroxide	NBZ3QY004S	IACT
Ethylhexylglycerin	147D247K3P	IACT
Butylated Hydroxytoluene	1P9D0Z171K	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 142 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Mineral Oil	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Lanolin Alcohols	LANOLIN ALCOHOLS	884C3FA9HE	CREAM / TOPICAL	6 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Magnesium Hydroxide	MAGNESIUM HYDROXIDE	NBZ3QY004S	TABLET, FILM COATED / ORAL	43.4 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.02 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Magnesium Hydroxide	MAGNESIUM HYDROXIDE	NBZ3QY004S	TABLET / ORAL		120 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Magnesium Hydroxide	MAGNESIUM HYDROXIDE	NBZ3QY004S	POWDER, FOR SUSPENSION / ORAL	0.01 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Magnesium Hydroxide	MAGNESIUM HYDROXIDE	NBZ3QY004S	TABLET, DELAYED RELEASE / ORAL		150 mg	Exact identifier — unii candidate 6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cadd20c2-a235-431a-b13b-13fbc102e6cf			38fcc371-0eab-46e1-a98a-3784e12aa9af	2010-11-19	Warnings	Exact identifier spl id: cadd20c2-a235-431a-b13b-13fbc102e6cf spl set id: 38fcc371-0eab-46e1-a98a-3784e12aa9af

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.