Diaper Rash
FDA Label NDC 50804-079

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Goodsense for the product Diaper Rash (NDC 50804-079). 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 other, active ingredient, purpose, uses, warnings, stop use and ask a doctor if, otc - 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

Other

Drug Facts

Distributed by:
Perrigo Direct, Inc.
Peachtree City, GA 30269

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.

Avoid contact with 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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

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 any time when exposure to wet diapers may be prolonged

Other Information

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients

aloe barbadensis leaf juice, BHA, cetyl alcohol, coconut butter, corn starch, fragrance, hydroxyethylcellulose, lanolin, methylparaben, mineral oil, petrolatum, polysorbate 20, purified water, shea butter

Questions Or Comments?

866-323-0107 or www.natureplex.com

Principal Display Panel - 56.7 G Tube Carton

GOODSENSE®
NDC 50804-079-01

Maximum Strength

Diaper Rash Paste

40% Zinc Oxide

Soothes Burning
Prevents Diaper Rash
Protects Skin

NET WT 2 oz (56.7 g)

Compare to active ingredients of
Desitin® Maximum Strength*

Principal Display Panel (56.7 g Tube Carton)

Principal Display Panel (56.7 g Tube Carton)

* Please review the disclaimer below.