GENTLE CARE KIT- zinc oxide kit

Gentle Care Kit by

Drug Labeling and Warnings

Gentle Care Kit by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Desitin Diaper Rash Ointment

Drug Facts

Active ingredient

Zinc Oxide (40%)

Purpose

Skin Protectant

Uses

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

Warnings

For external use only.

When using this product do not get into eyes

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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

store at 20°C to 25°C (68°F to 77°F)

may stain clothing

Inactive ingredients

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

Questions?

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

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC
Summit, NJ 07901

Infants' TYLENOL

Drug Facts

Active ingredient

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

Warnings

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

▪ 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

Ask a doctor before use if your child has liver disease

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

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

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.

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

▪ 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 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5

* 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

▪ 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

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

Questions or comments?

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

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

INGREDIENTS AND APPEARANCE

GENTLE CARE KIT 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0964

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0964-9	1 in 1 KIT	11/20/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CAN	88 mL
Part 2	1 BOTTLE	30 mL
Part 3	1 BOTTLE	400 mL
Part 4	1 TUBE	57 g

Part 1 of 4

ZARBEES SOOTHING SALINE NASAL MIST WITH ALOE 
other baby products, leave-on [baby products] liquid

Product Information
Route of Administration	NASAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		88 mL in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/30/2024

Part 2 of 4

INFANTS TYLENOL 
acetaminophen suspension

Product Information
Item Code (Source)	NDC: 50580-599
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL SOLUTION (UNII: 8KW3E207O2)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	white (Dye Free)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-599-03	1 in 1 CARTON
1		30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	04/20/2020

Part 3 of 4

JOHNSONS BABY HEAD TO TOE WASH AND SHAMPOO 
baby shampoos [baby products] liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	CITRIC ACID (UNII: 2968PHW8QP)
INGR	ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	WATER (UNII: 059QF0KO0R)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
INGR	PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
INGR	SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		400 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		07/25/2025

Part 4 of 4

DESITIN MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH 
zinc oxide paste

Product Information
Item Code (Source)	NDC: 69968-0848
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
COD LIVER OIL (UNII: BBL281NWFG)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
BEESWAX (UNII: 2ZA36H0S2V)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
ZEA MAYS (CORN) STARCH (UNII: O8232NY3SJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0848-2	1 in 1 CARTON
1		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	05/27/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	11/20/2025

Labeler - Kenvue Brands LLC (118772437)