FDA.reportPublic FDA data

Tom's ® Baby Diaper Cream Fragrance Free

Manufacturer
Tom's of Maine | Accupac, Inc.
Effective date
2019-11-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:55:47

Label at a glance#

ProductToms Baby Diaper Fragrance Free
Active ingredientZinc Oxide
Label structure11 sections

Indications and uses

helps treat and prevent diaper rash. protects minor skin irritation associated with diaper rash and helps seal out wetness.

Dosage and administration

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

Storage and handling

Store at 20°C to 25°C (68° F to 77° F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 12%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash.
  • protects minor skin irritation associated with diaper rash and helps seal out wetness.

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask doctor if condition worsens

  • symptoms last more than 7 days or clear up and occur within 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, and allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive ingredients

INACTIVE INGREDIENT SECTION

caprylic/capric triglyceride, Helianthus annuus (sunflower) seed oil, beeswax, hydrogenated castor oil, tocopheryl acetate (vitamin E acetate).

Other information

STORAGE AND HANDLING SECTION

Store at 20°C to 25°C (68° F to 77° F).

Questions?

OTC - QUESTIONS SECTION

1-800-FOR TOMS (1-800-367-8667)

SPL UNCLASSIFIED SECTION

Dist. by Tom's of Maine, Inc., Kennebunk, ME 04043

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New!

SINCE 1970
Tom's®
OF MAINE

baby

diaper cream

seals out wetness to help
treat & prevent diaper rash

pediatrician tested

fragrance free

natural

✓ NO Phthalates
✓ NO Parabens
✓ NO Phenoxyethanol

NET WT 3 OZ (85g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label
PRINCIPAL DISPLAY PANEL - 85 g Tube Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z2
Zinc OxideACTIVE MOIETYSOI2LOH54Z2
.Alpha.-Tocopherol Acetate, dl-INACTIVE INGREDIENTWR1WPI7EW82
Caprylic/Capric AcidINACTIVE INGREDIENTDI775RT2442
Hydrogenated castor oilINACTIVE INGREDIENTZF94AP8MEY2
Sunflower OilINACTIVE INGREDIENT3W1JG795YI2
Yellow WaxINACTIVE INGREDIENT2ZA36H0S2V2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51009-70151009-701-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Caprylic/Capric AcidDI775RT244IACT
Sunflower Oil3W1JG795YIIACT
Yellow Wax2ZA36H0S2VIACT
Hydrogenated castor oilZF94AP8MEYIACT
.Alpha.-Tocopherol Acetate, dl-WR1WPI7EW8IACT

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 1 · 23 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYTABLET, FOR SUSPENSION / ORAL17 mgExact identifier — unii candidate
12 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYTABLET / ORAL232 mgExact identifier — unii candidate
12 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE / ORAL405 mgExact identifier — unii candidate
12 equally ranked IID candidates
.Alpha.-Tocopherol Acetate, dl-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8AEROSOL, FOAM / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
.Alpha.-Tocopherol Acetate, dl-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8OINTMENT / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii candidate
12 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYTABLET, EXTENDED RELEASE / ORAL393 mgExact identifier — unii candidate
12 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
12 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYTABLET, FILM COATED / ORAL17 mgExact identifier — unii candidate
12 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE, DELAYED RELEASE / ORAL3.1 mgExact identifier — unii candidate
12 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE, EXTENDED RELEASE / ORAL410.82 mgExact identifier — unii candidate
12 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYTABLET, DELAYED RELEASE / ORAL1337 mgExact identifier — unii candidate
12 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
Hydrogenated castor oilHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii candidate
12 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
38954599-b1a0-423e-962e-2a4066a169a98fef4216-cca7-487d-b3c8-d8f2449a21412019-11-20WarningsExact identifier
spl id: 38954599-b1a0-423e-962e-2a4066a169a9
spl set id: 8fef4216-cca7-487d-b3c8-d8f2449a2141

Reported adverse events (FAERS/openFDA)#

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