Desitin Diaper Rash Ointment
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Desitin Maximum Strength Zinc Oxide Diaper Rash (NDC 69968-0848). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding desitin diaper rash ointment, active ingredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Zinc Oxide (40%)
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Skin Protectant
Pain reliever/fever reducer
temporarily:
For external use only.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
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.
When using this product • do not get into eyes
When using this product do not exceed recommended dose (see overdose warning)
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
Stop use and ask a doctor if
These could be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.
▪ 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.
• store at 20°C to 25°C (68°F to 77°F)
• may stain clothing
▪ store between 20-25°C (68-77°F)
▪ do not use if carton tape or bottle wrap imprinted with “TYLENOL” is broken or missing
Petrolatum, Cod Liver Oil, Lanolin, Zea Mays (Corn) Starch, Glycerin, Beeswax, Sorbitan Sesquioleate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopheryl Acetate, Fragrance
anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum
Call toll-free 800-720-3843 or 215-273-8755 (collect)
Distributed by:
Kenvue Brands LLC
Summit, NJ 07901
Distributed by:
Kenvue Brands LLC
Summit, NJ 07901
Drug Facts
▪ 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
call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)
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
* Please review the disclaimer below.