FDA.reportPublic FDA data

Johnsons Baby Care Essentials Gift Set

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:39:31

Label at a glance#

ProductJohnsons Baby Care Essentials Gift Set
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 paste 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) may stain clothing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DESITIN ® Maximum Strength Zinc Oxide Diaper Rash Paste

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 40%

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 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 paste 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°C to 25°C (68°F to 77°F)
  • may stain clothing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolatum, Cod Liver Oil, Lanolin, Talc, Glycerin, Sorbitan Sesquioleate, Beeswax, Tocopheryl Acetate, Fragrance

Questions?

OTC - QUESTIONS SECTION

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

For more information on preventing and treating diaper rash, visit www.desitin.com

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JOHNSON'S®

baby care essentials

value

pack

all products are

TSA compliant!

Includes JOHNSON'S® HEAD-TO TOE® wash and shampoo 3.4 FL OZ (100 mL) ● JOHNSON'S® baby lotion 3.4 FL OZ (100 mL)

DESITIN® Maximum Strength Zinc Oxide Diaper Rash Paste 1 OZ (28 g)

JOHNSONJOHNSON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1797059Desitin 40 % Topical PastePSN3
1094560zinc oxide 40 % Topical PastePSN3
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD3
1094560zinc oxide 0.4 MG/MG PasteSCD3
1797059Desitin 40 % Topical PasteSY3
1094560zinc oxide 40 % PasteSY3
1094560ZNO 0.4 MG/MG PasteSY3
1797059ZNO 0.4 MG/MG Paste [Desitin]SY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0061-1Johnsons Baby Care Essentials Gift Set1 in 1 CARTONPASTE400 mg in 1g3
69968-0061-1Johnsons Baby Care Essentials Gift Set28 g in 1 TUBEPASTE28 g400 mg in 1g3
69968-0789-9Johnsons Baby Care Essentials Gift Set1 in 1 PACKAGEKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0061JOHNSONS BABY CARE ESSENTIALS GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]3Current NDC, Legacy NDC20241127_ed08b690-f907-6d2f-e053-2a95a90af51c.zip
69968-0789JOHNSONS BABY CARE ESSENTIALS GIFT SET (ZINC OXIDE) KIT [KENVUE BRANDS LLC]3Current NDC, 3 package rows20241127_ed08b690-f907-6d2f-e053-2a95a90af51c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0061-1GM - Gram69968-0061f10dbdb2-0d9b-41ce-b70a-58f111649b9f12021-06-02

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-078969968-0789-9
69968-006169968-0061-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
COD LIVER OILBBL281NWFGIACT
LANOLIN7EV65EAW6HIACT
TALC7SEV7J4R1UIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
YELLOW WAX2ZA36H0S2VIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
PEG-80 SORBITAN LAURATE239B50Y732INGR
GLYCERINPDC6A3C0OXINGR
PEG-150 PENTAERYTHRITYL TETRASTEARATE8L4OOQ76AMINGR
PPG-2 HYDROXYETHYL COCAMIDE34N07GUJ3XINGR
PHENOXYETHANOLHIE492ZZ3TINGR
SODIUM METHYL COCOYL TAURATEJVL98CG53GINGR
SODIUM BENZOATEOJ245FE5EUINGR
DECYL GLUCOSIDEZ17H97EA6YINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
PHENOXYETHANOLHIE492ZZ3TINGR
POLYSORBATE 207T1F30V5YHINGR
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCINGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR
P-ANISIC ACID4SB6Y7DMM3INGR
SODIUM HYDROXIDE55X04QC32IINGR
XANTHAN GUMTTV12P4NEEINGR
ETHYLHEXYLGLYCERIN147D247K3PINGR
TITANIUM DIOXIDE15FIX9V2JPINGR
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
ISOPROPYL PALMITATE8CRQ2TH63MINGR
STEARIC ACID4ELV7Z65APINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
CETYL ALCOHOL936JST6JCNINGR
COCONUT OILQ9L0O73W7LINGR
CETOSTEARYL ALCOHOL2DMT128M1SINGR

Source Document#

Source XML

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCed08b690-f907-6d2f-e053-2a95a90af51c2024-11-25WarningsExact identifier
ndc (package): 69968-0061-1
ndc (package): 69968-0789-9
ndc (product): 69968-0789
ndc11 (package): 69968078909
ndc11 (package): 69968006101
spl id: 224b8e34-f325-7c72-e063-6394a90a97c1
spl set id: ed08b690-f907-6d2f-e053-2a95a90af51c
Desitin Maximum Strength Diaper RashZINC OXIDEKenvue Brands LLCaf64fc2f-c027-4a68-b368-ee06744a24522024-11-15WarningsExact identifier
ndc (package): 69968-0061-1
ndc (product): 69968-0061
ndc11 (package): 69968006101
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCafa1ba48-b504-4af0-a9c7-cd2c9a2e6e592024-11-13WarningsExact identifier
ndc (package): 69968-0061-1
ndc11 (package): 69968006101

Reported adverse events (FAERS/openFDA)#

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