Quality Choice Maximum Strength Diaper Rash
FDA Label NDC 63868-165

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Quality Choice Maximum Strength Diaper Rash (NDC 63868-165). 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

Maximum Strength Diaper Rash Paste
With 40% Zinc Oxide

Helps To Heal, Soothe & Prevent Diaper Rash

NET WT 4 OZ. (113 g)

*Compare to DESITIN® MAXIMUM STRENGTH

Maximum Strength Original Diaper Rash Paste 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 C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

Manufactured in Israel
0D927 CD C1

SATISFACTION GUARANTEED

Carton Label (5bec85c7 D69c 4ca7 A345 950cc030f41e 01)

Carton Label (5bec85c7 D69c 4ca7 A345 950cc030f41e 01)

Carton Label

* Please review the disclaimer below.