Label: GENTLE CARE KIT- zinc oxide kit
- NDC Code(s): 50580-599-03, 69968-0848-2, 69968-0964-9
- Packager: Kenvue Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 24, 2026
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Desitin Diaper Rash Ointment
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- Infants' TYLENOL
- Active ingredient
- Purpose
- Uses
-
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
-
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
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
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 kitProduct 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] liquidProduct 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 suspensionProduct 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] liquidProduct 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 pasteProduct 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)
