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DESITIN Maximum Strength Zinc Oxide Diaper Rash
Drug Facts
Distributed by:
Kenvue Brands LLC
Summit, NJ 07901
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Johnsons First Touch Baby Gift Set (NDC 69968-0906). 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 other, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
DESITIN Maximum Strength Zinc Oxide Diaper Rash
Drug Facts
Distributed by:
Kenvue Brands LLC
Summit, NJ 07901
Zinc Oxide (40%)
Skin Protectant
• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness
For external use only
• do not get into eyes
• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
If swallowed, get medical help or contact a Poison Control Center right away.
• 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
• store at 20°C to 25°C (68°F to 77°F) • may stain clothing
Petrolatum, Cod Liver Oil, Lanolin, Zea Mays (Corn) Starch, Glycerin, Beeswax, Sorbitan Sesquioleate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopheryl Acetate, Fragrance
Call toll-free 800-720-3843 or 215-273-8755 (collect)
World’s
# 1
Baby
& Child
Care
Brand*
Johnson’s®
baby
first touch
gift set
value
pack
Step 1
Gently
Cleanse
Step 2
Moisturize
Baby’s
Delicate
Skin
Healthy Skin
=
Happier Baby
Our 2 Step bath time
routine formulas
designed to
work together!
a selection of gentle products to cleanse,
moisturize, and care for baby’s delicate skin
Hypoallergenic, no parabens or dyes
*Source Euromonitor International
Limited; Beauty and Personal Care 2023
ed. as per Baby and Child-Specific Products
category; all retail channels; value sales at
RSP; 2022 data.
Includes:
JOHNSON’S® HEAD-TO-TOE® wash & shampoo 13.6 FL OZ (400 mL)
DESITIN® Maximum Strength Zinc Oxide Diaper Rash Cream 2 OZ (57 g)
JOHNSON’S® baby lotion 13.6 FL OZ (400 mL)
* Please review the disclaimer below.