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.

  • 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 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

    ▪ 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

    PDP_Kit Label

  • INGREDIENTS AND APPEARANCE
    GENTLE CARE KIT 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0964
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0964-91 in 1 KIT11/20/2025
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CAN 88 mL
    Part 21 BOTTLE 30 mL
    Part 31 BOTTLE 400 mL
    Part 41 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 AdministrationNASAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)  
    INGRWATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    188 mL in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/30/2024
    Part 2 of 4
    INFANTS TYLENOL 
    acetaminophen suspension
    Product Information
    Item Code (Source)NDC:50580-599
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorwhite (Dye Free) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-599-031 in 1 CARTON
    130 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/20/2020
    Part 3 of 4
    JOHNSONS BABY HEAD TO TOE WASH AND SHAMPOO 
    baby shampoos [baby products] liquid
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCITRIC ACID (UNII: 2968PHW8QP)  
    INGRALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRPEG-80 SORBITAN LAURATE (UNII: 239B50Y732)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    INGRPEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    INGRPPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1400 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic07/25/2025
    Part 4 of 4
    DESITIN MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH 
    zinc oxide paste
    Product Information
    Item Code (Source)NDC:69968-0848
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0848-21 in 1 CARTON
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/27/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/20/2025
    Labeler - Kenvue Brands LLC (118772437)