Diaper Rash Paste
FDA Label NDC 11344-020

14 label sections · Submitted to the FDA by Nice-pak Products, Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Diaper Rash (NDC 11344-020). 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 ingredient, 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 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 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

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor fo Desitin ® Maximum Strength 40% Zinc Oxide Diaper Rash Paste.

Adverse Reactions

Distributed by: Nice-Pak Products, LLC

8800 Page Ave., St. Louis, MO 63114 1-888-593-0593

Claims

Dermatologist Tested

Pediatrician Tested

Hypoallergenic**

**Individual skin sensitivites may vary.

Principal Display Panel

*COMPARE TO DESITIN ®MAXIMUM STRENGTH DIAPER RASH PASTE

SIMPLY U  ®BABY

40% ZINC OXIDE

diaper rash ointment

SKIN PROTECTANT

helps heal, soothe, & prevent diaper rash

FREE FROM PARABENS, PHTHALATES & DYES

NET WT 4 OZ (113 g)

Image Description (Mm02)

Image Description (Mm02)

Swan baby

Compare to Desitin ®Maximum Strength Diaper Rash Paste*

maximum strength

diaper rash ointment

skin protectant/40% zinc oxide

  • helps heal, soothe, & prevent diaper rash
  • paraben, phthalate and quaternium-15 free
  • pediatrician and dermatologist tested

    • NET WT 4 OZ (113 g)

    Image Description (Mm01)

    Image Description (Mm01)

* Please review the disclaimer below.