Diaper Rash Ointment
FDA Label NDC 41163-020

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Diaper Rash (NDC 41163-020). 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, use, 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

Use

  • 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

Questions?

Call 1-877-932-7948

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Destin Maximum Strength Original Paste.

Adverse Reactions

DISTRIBUTED BY SUPERVALU, INC

EDEN PRAIRIE, MN 55344

www.supervalu-ourownbrands.com

020.002/AC

Principal Display Panel

NDC 41163-020-26

Baby

Basics

Compare to the active ingredient in Desitin Maximum Strength Original Paste

Zinc Oxide

DIAPER RASH

OINTMENT

Skin Protectant

  • Helps Promote Healing
  • Protects Chafed Skin
  • Hypoallergenic

    • Net Wt 4 OZ (113 g)

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* Please review the disclaimer below.