tena_essity 226.002/226ad

tena_essity 226.002/226ad
SPL v7
SPL
SPL Set ID b840377f-a297-4aff-900e-7ea8b7c98717
Route
topical
Published
Effective Date 2025-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (130 mg)
Inactive Ingredients
water mineral oil petrolatum yellow wax dimethicone sorbitan sesquioleate microcrystalline wax peg-30 dipolyhydroxystearate aloe vera leaf glycerin tropolone .alpha.-tocopherol acetate 1,2-hexanediol caprylyl glycol magnesium sulfate, unspecified form potassium hydroxide phenoxyethanol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-10-25

Purpose

Skin protectant

Description

Zinc oxide 13%


Medication Information

Warnings

For external use only

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Purpose

Skin protectant

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 59º and 86º F (15º and 30º C). Do not use if security seal on tube is broken or missing.

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

Description

Zinc oxide 13%

Questions?

Call 1-866-275-8362 or visit www.tena.us

Claims

For adult use

Not made with natural rubber latex.

DERMATOLOGICALLY APPROVED

essity

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

Adverse Reaction

Manufactured for

Essity HMS North America Inc.

Cira Centre, Suite 2600

2929 Arch Street

Philadelphia, PA 19104

Active Ingredient

Zinc oxide 13%

Principal Panel Display

TENA ®

Proskin ®

Protective Cream

Protects Sensitive Skin

Fragrance Free

Skin Protectant

13% Zinc Oxide

Net WT 4 OZ (113 g)

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.


Structured Label Content

Warnings

For external use only

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Purpose

Skin protectant

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 (Other information)

store between 59º and 86º F (15º and 30º C). Do not use if security seal on tube is broken or missing.

Inactive Ingredients (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

Claims

For adult use

Not made with natural rubber latex.

DERMATOLOGICALLY APPROVED

essity

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

Adverse Reaction (Adverse reaction)

Manufactured for

Essity HMS North America Inc.

Cira Centre, Suite 2600

2929 Arch Street

Philadelphia, PA 19104

Active Ingredient (Active ingredient)

Zinc oxide 13%

Principal Panel Display

TENA ®

Proskin ®

Protective Cream

Protects Sensitive Skin

Fragrance Free

Skin Protectant

13% Zinc Oxide

Net WT 4 OZ (113 g)

When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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