FDA.reportPublic FDA data

Desitin Rapid Relief Diaper Rash Cream

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2020-08-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:17:03

Label at a glance#

ProductDesitin Rapid Relief Diaper Rash
Active ingredientZinc Oxide
Label structure11 sections

Indications and uses

Helps treat and prevent diaper rash Protects chafed skin due to 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, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Storage and handling

Store at 20° to 25°C (68° to 77°F) Protect from freezing May stain clothing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 13%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few day

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, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

STORAGE AND HANDLING SECTION

  • Store at 20° to 25°C (68° to 77°F)
  • Protect from freezing
  • May stain clothing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Aloe Barbadensis Leaf Extract , Glycerin , Tropolone, Tocopheryl Acetate, 1,2-Hexanediol Caprylyl Glycol, Magnesium Sulfate, Potassium Hydroxide, Phenoxyethanol

Questions?

OTC - QUESTIONS SECTION

Call toll-free 800-720-3843 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed in the U.S. by:
JOHNSON & JOHNSON
CONSUMER PRODUCTS COMPANY
Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 CHOICE OF
PEDIATRICIANS & MOMS

NEW
FORMULA

Desitin®
Rapid Relief

relieves discomfort
in one application

Paraben-free
Fragrance-free          Zinc Oxide Diaper Rash Cream          NET WT 4 Oz (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L01
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0X1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Magnesium SulfateINACTIVE INGREDIENTDE08037SAB1
Microcrystalline WaxINACTIVE INGREDIENTXOF597Q3KY1
Mineral OilINACTIVE INGREDIENTT5L8T28FGP1
PEG-30 DipolyhydroxystearateINACTIVE INGREDIENT9713Q0S7FO1
PetrolatumINACTIVE INGREDIENT4T6H12BN9U1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4T1
Sorbitan SesquioleateINACTIVE INGREDIENT0W8RRI5W5A1
TropoloneINACTIVE INGREDIENT7L6DL16P1T1
WaterINACTIVE INGREDIENT059QF0KO0R1
Yellow WaxINACTIVE INGREDIENT2ZA36H0S2V1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58232-992658232-9926-0, 58232-9926-2, 58232-9926-4, 58232-9926-5, 58232-9926-6, 58232-9926-8, 58232-9926-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Mineral OilT5L8T28FGPIACT
Petrolatum4T6H12BN9UIACT
Yellow Wax2ZA36H0S2VIACT
Dimethicone92RU3N3Y1OIACT
Sorbitan Sesquioleate0W8RRI5W5AIACT
Microcrystalline WaxXOF597Q3KYIACT
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
Aloe Vera LeafZY81Z83H0XIACT
GlycerinPDC6A3C0OXIACT
Tropolone7L6DL16P1TIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Magnesium Sulfate, Unspecified FormDE08037SABIACT
Potassium HydroxideWZH3C48M4TIACT
PhenoxyethanolHIE492ZZ3TIACT

Source Document#

Source XML · Source PDF

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 · 166 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Magnesium SulfateMAGNESIUM SULFATEDE08037SABTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
Potassium HydroxidePOTASSIUM HYDROXIDEWZH3C48M4TINJECTION / INTRAVENOUSADJ PHExact identifier — unii candidate
13 equally ranked IID candidates
Microcrystalline WaxMICROCRYSTALLINE WAXXOF597Q3KYCAPSULE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
4 equally ranked IID candidates
Potassium HydroxidePOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, LIQUID FILLED / ORAL154 mgExact identifier — unii candidate
13 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
Potassium HydroxidePOTASSIUM HYDROXIDEWZH3C48M4TCREAM / TOPICAL0.5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Potassium HydroxidePOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii candidate
13 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Microcrystalline WaxMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii candidate
4 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Microcrystalline WaxMICROCRYSTALLINE WAXXOF597Q3KYCREAM / VAGINAL23 mgExact identifier — unii candidate
4 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
Potassium HydroxidePOTASSIUM HYDROXIDEWZH3C48M4TSOLUTION / TOPICAL14.02 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 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
23c53a56-017c-4c58-9164-79e5243809aadc9003d9-9019-4a61-a5f8-e448600a60852020-08-21WarningsExact identifier
spl id: 23c53a56-017c-4c58-9164-79e5243809aa
spl set id: dc9003d9-9019-4a61-a5f8-e448600a6085

Reported adverse events (FAERS/openFDA)#

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