TENA PROSKIN PROTECTIVE CREAM- zinc oxide cream

TENA Proskin protective cream by

Drug Labeling and Warnings

TENA Proskin protective cream by is a Otc medication manufactured, distributed, or labeled by Essity HMS North America Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

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

Principal Panel Display

TENA ®

Proskin ®

Protective Cream

Protects Sensitive Skin

Fragrance Free

Skin Protectant

13% Zinc Oxide

Net WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

TENA PROSKIN PROTECTIVE CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59608-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	130 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
TROPOLONE (UNII: 7L6DL16P1T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59608-017-01	1 in 1 CARTON	10/25/2022
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/25/2022

Labeler - Essity Professional Hygiene North America LLC  (787850148)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(59608-017)