Dermogen Cream
FDA Label NDC 52083-680

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Dermogen (NDC 52083-680). 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 drug facts, active ingredient, purpose, otc - keep out of reach of children, uses, warnings, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Zinc Oxide 15.25%

Purpose

Skin protectant

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.

Uses

 • helps treat and prevent diaper rash 

 • protects chafed skin due to diaper rash and helps seal out wetness

Warnings

Warning •For external use only.

When using this product • do not get in to eyes

Stop and ask a doctor if • condition worsens •symptoms lasts more than 7 days or clear up and occur again within a few days

Directions

• change wet or soiled diapers promptly. • cleanse the diaper area • allow to dry • apply cream liberally as often as necessary, with each diaper, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive Ingredient

Inactive Ingredients Butylhydroxytoluene, diazolidinyl urea, fragrance, methylparaben, mineral oil, propylene glycol, propylparaben, Vitamin A, Vitamin D, Vitamin E and white petrolatum.

Storage And Handling

Other information • Store at controlled room temperature 15° -30°C (59° -86°F). • Do not use if seal is broken

Other

Skin Protectant

For the Treatment & Prevention of Diaper Rash

Manufactured in the USA for Kramer Novis,
San Juan, PR 00917. T: (787) 767-2072.
www.kramernovis.com

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