Tena Proskin Protective Cream
FDA Label NDC 59608-017

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Essity Professional Hygiene North America Llc� for the product Tena Proskin Protective Cream (NDC 59608-017). 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 13%

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 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 20° and 25°C (68° and 77° F)

Inactive Ingredients

water, mineral oil, petrolatum, beeswax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxystearate, Aloe barbadensis leaf juice, glycerin, tropolone, tocopheryl acetate, 1,2-hexanediol, caprylyl glycol, magnesium sulfate, potassium hydroxide, phenoxyethanol

Questions?

Call 1-866-275-8362

or visit www.tena.us

Other

Not made with natural rubber latex.

essity

Manufactured for Essity HMS North America Inc.

Cira Centre, Suite 2600

2929 Arch Street

Philadelphia, PA 19104

Made in the U.S. with U.S. and foreign components.

Principal Panel Display

TENA

Proskin

Protective Cream

Protects Sensitive Skin

Fragrance Free

Skin Protectant

13% Zinc Oxide

Net WT 4 OZ (113 g)

Image Description (Mm1)

Image Description (Mm1)

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