Gentle Care Kit

Manufacturer
Kenvue Brands LLC
Effective date
2026-02-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:47:44

Label at a glance#

ProductGentle Care Kit
Active ingredientACETAMINOPHEN, ZINC OXIDE
Label structure21 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#

Desitin Diaper Rash Ointment

SPL UNCLASSIFIED SECTION

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.

OTC - WHEN USING SECTION

When using this product • do not get into eyes

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 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, Zea Mays (Corn) Starch, Glycerin, Beeswax, Sorbitan Sesquioleate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopheryl Acetate, Fragrance

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC
Summit, NJ 07901

Infants' TYLENOL

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • the common cold ▪ flu ▪ headache ▪ sore throat ▪ toothache

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

  • skin reddening ▪ blisters ▪ rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

▪ if your child is allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose (see overdose warning)

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present.

These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

▪ this product does not contain directions or complete warnings for adult use.

▪ do not give more than directed (see overdose warning)
▪ shake well before using
▪ mL = milliliter

▪ find right dose on chart below. If possible, use weight to dose; otherwise, use age.
▪ push air out of syringe. Insert syringe tip into bottle opening
▪ flip bottle upside down. Pull yellow part of syringe to correct dose
▪ dispense liquid slowly into child’s mouth, toward inner cheek
▪ repeat dose every 4 hours while symptoms last
▪ do not give more than 5 times in 24 hours

▪ replace cap tightly to maintain child resistance

Dosing Chart

Weight (lb)Age (yr)Dose (mL)*
under 24under 2 yearsask a doctor
24-35 lbs2-3 years5

* or as directed by a doctor

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

▪ store between 20-25°C (68-77°F)

▪ do not use if carton tape or bottle wrap imprinted with “TYLENOL” is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC

Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gentle

Care Kit

For all baby’s firsts

VALUE

PACK

pain/fever

gentle cleansing

stuffy noses

diaper rash

Pediatrician recommended brands

Infants’ TYLENOL ®

Dye-Free

1 fl oz (30 mL)

JOHNSON’S ® baby HEAD-TO-TOE ®

Wash & Shampoo

13.6 FL. OZ. (400 mL)

ZARBEE’S ® Soothing Saline

Nasal Mist with Aloe

3 FL. OZ. (88 mL)

DESITIN ®

Max Strength Paste

NET WT 2 Oz (57 g)

Use products only as directed

products shown are not sized to scale

PDP_Kit LabelPDP_Kit Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN1
1797059Desitin 40 % Topical PastePSN1
828555Tylenol 160 MG in 5 mL Oral SuspensionPSN1
1094560zinc oxide 40 % Topical PastePSN1
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBD1
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD1
307668acetaminophen 32 MG/ML Oral SuspensionSCD1
1094560zinc oxide 0.4 MG/MG PasteSCD1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY1
307668APAP 32 MG/ML Oral SuspensionSY1
828555APAP 32 MG/ML Oral Suspension [Tylenol]SY1
1797059Desitin 40 % Topical PasteSY1
828555Tylenol 160 MG per 5 ML Oral SuspensionSY1
828555Tylenol 32 MG/ML Oral SuspensionSY1
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSY1
1094560zinc oxide 40 % PasteSY1
1094560ZNO 0.4 MG/MG PasteSY1
1797059ZNO 0.4 MG/MG Paste [Desitin]SY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130381372026370GTIN-13: 0381372026370
EAN-13: 0381372026370
GTIN-12: 381372026370
UPC-A: 381372026370
GTIN storage (14 digits): 00381372026370
69968-0964_Kit Label.jpg
QR code linkQR Codeqrco.de/Head2ToeGiftSet69968-0964_Kit Label.jpg
Data codeData Matrix3006135769968-0964_Kit Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
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20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-599-03Gentle Care Kit1 in 1 CARTONSUSPENSION160 mg in 5mL1
50580-599-03Gentle Care Kit30 mL in 1 BOTTLESUSPENSION30 mL160 mg in 5mL1
69968-0848-2Gentle Care Kit1 in 1 CARTONPASTE400 mg in 1g1
69968-0848-2Gentle Care Kit57 g in 1 TUBEPASTE57 g400 mg in 1g1
69968-0964-9Gentle Care Kit1 in 1 KITKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-599-01ML - Milliliter50580-599f23bdcb2-a6bf-4c37-b48f-ef996e84244012020-05-08

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-096469968-0964-9
50580-59950580-599-03
69968-084869968-0848-2

Ingredients#

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

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

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentle Care KitZINC OXIDEKenvue Brands LLC4b8f7a5a-2fc4-ea00-e063-6294a90ab95b2026-02-24WarningsExact identifier
ndc (package): 69968-0964-9
ndc (package): 69968-0848-2
ndc (package): 50580-599-03
ndc (product): 69968-0964
ndc11 (package): 69968084802
ndc11 (package): 50580059903
ndc11 (package): 69968096409
spl id: 4b8f7031-898e-0ea2-e063-6394a90ae5cc
spl set id: 4b8f7a5a-2fc4-ea00-e063-6294a90ab95b
Johnsons Baby First Touch Gift SetZINC OXIDEKenvue Brands LLC3f838eb7-42a3-c96b-e063-6294a90a74912025-09-26WarningsExact identifier
ndc (package): 69968-0848-2
ndc11 (package): 69968084802
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1590101a-c968-fca5-e063-6394a90a7ccc2025-02-28WarningsExact identifier
ndc (package): 69968-0848-2
ndc (product): 69968-0848
ndc11 (package): 69968084802
Infants TYLENOLACETAMINOPHENKenvue Brands LLCf9de7c2f-016b-4f40-8b5e-141ad194be972025-02-20WarningsExact identifier
ndc (package): 50580-599-03
ndc (product): 50580-599
ndc11 (package): 50580059903
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLC2c2337cf-4507-7232-e063-6294a90a79c32025-01-20WarningsExact identifier
ndc (package): 69968-0848-2
ndc11 (package): 69968084802

Reported adverse events (FAERS/openFDA)#

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