Shopko Diaper Rash Maximum Strength
FDA Label NDC 37012-927

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shopko Stores Operating Co., Llc for the product Shopko Diaper Rash Maximum Strength (NDC 37012-927). 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........40.0%

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 cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other Information

  • store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

cod liver oil, talc, petrolatum, lanolin, water, methylparaben, fragrance, BHA

Package/Label Principal Display Panel

SHOPKO®

Diaper Rash Paste Maximum Strength

40% Zinc Oxide

Helps Heal, Soothe & Prevent Diaper Rash

Compare to Desitin® Maximum Strength Original Paste 40% Zinc Oxide Diaper Rash Paste Ingredients

NET WT 4 OZ (113 g)

SHOPKO® Diaper Rash Paste Maximum Strength provides overnight relief for your baby's delicate skin. This rich, dermatologist-tested and hypoallergenic formula contains the maximum level of zinc oxide to instantly form a protective barrier to help heal and soothe discomfort caused by diaper rash.

*This product is not manufactured or distributed by Johnson & Johnson® Consumer Products Company, owner of the registered trademark Desitin®

Distributed by Emilia Personal Care Inc.
5890 Sawmill Road, Suite 230, Dublin, OH 43017
Questions? Call 1-866-543-5125
Made in Israel
SHOPKO® Satisfaction Guaranteed
By Refund or Exchange
©2013 ShopKo Stores Operating Co., LLC
0D927 8C C1

Shopko Diaper Rash Paste Label (28c365af C8d0 4e39 Ace1 58eb04f862a5 01)

Shopko Diaper Rash Paste Label (28c365af C8d0 4e39 Ace1 58eb04f862a5 01)

Carton Label

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