Diaper Rash Paste
FDA Label NDC 36800-020

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Diaper Rash (NDC 36800-020). 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 active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

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 soilded diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply ointment 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 between 20⁰ and 25⁰C (68⁰ and 77⁰F)

Inactive Ingredients

petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

Adverse Reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007 1-888-423-0139

tippytoesbytopcare.com

020.002/020AC

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company,

distributor of Desitin Maximum Strength Original Paste.

Principal Display Panel

NDC 36800-020-26

tippy toes

by TopCare

40% zinc oxide

diaper rash ointment

skin protectant

helps heal, soothe & prevent diaper rash

hypoallergenic

maximum strength

COMPARE TO DESITIN MAXIMUM STRENGTH ORIGINAL PASTE

NET WT 4 OZ (113 g)

* Please review the disclaimer below.