SPL v3
SPL
SPL Set ID fe115e44-e97d-4cbc-8ec8-ebcae7f9e3f3
Route
TOPICAL
Published
Effective Date 2017-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (10 g)
Inactive Ingredients
Acacia Decurrens Flower Wax Medium-chain Triglycerides Citric Acid Monohydrate Dicaprylyl Carbonate Ethylhexylglycerin Glycerin Helianthus Annuus Seed Wax Hydrogenated Jojoba Oil, Randomized Magnesium Sulfate, Unspecified Form Yellow Wax Phenoxyethanol Polyglycerin-3 Polyglyceryl-3 Ricinoleate Potassium Sorbate Sodium Benzoate Sodium Citrate Sodium Gluconate Sorbitan Sorbitan Isostearate Tocopherol Corn Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-06-07

Description

Active Ingredient Zinc Oxide 10%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use •on deep or puncture wounds  •on animal bites  •on serious burns

When using this product  •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

Indications and Usage

Uses

•helps treat and prevent skin rashes due to incontinence

•protects chafed skin due to incontinence and helps seal out wetness

Dosage and Administration

Directions

•cleanse skin with TENA® Cleansing Cream and/or TENA® Washcloths

•apply cream sparingly and reapply as needed

Description

Active Ingredient Zinc Oxide 10%

Section 44425-7

Other information Store between 32° F and 85° F

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a

Poison Control Center immediately

Section 51727-6

Inactive ingredients:  Acacia Decurrens Flower Wax, Caprylic/Capric Triglyceride, Citric Acid, Dicaprylyl Carbonate,

Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Wax, Jojoba Esters, Magnesium Sulfate, PEG-8 Beeswax, Polyglycerin-3,

Polyglyceryl-3 Ricinoleate, Potassium Sorbate, Sodium Benzoate, Sodium Citrate, Sodium Gluconate, Sorbitan Caprylate, Sorbitan

Isostearate, Tocopherol, Vegetable Oil, Water.

Section 51945-4

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredient

Zinc Oxide 10%


Structured Label Content

Indications and Usage (34067-9)

Uses

•helps treat and prevent skin rashes due to incontinence

•protects chafed skin due to incontinence and helps seal out wetness

Dosage and Administration (34068-7)

Directions

•cleanse skin with TENA® Cleansing Cream and/or TENA® Washcloths

•apply cream sparingly and reapply as needed

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use •on deep or puncture wounds  •on animal bites  •on serious burns

When using this product  •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

Section 44425-7 (44425-7)

Other information Store between 32° F and 85° F

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a

Poison Control Center immediately

Section 51727-6 (51727-6)

Inactive ingredients:  Acacia Decurrens Flower Wax, Caprylic/Capric Triglyceride, Citric Acid, Dicaprylyl Carbonate,

Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Wax, Jojoba Esters, Magnesium Sulfate, PEG-8 Beeswax, Polyglycerin-3,

Polyglyceryl-3 Ricinoleate, Potassium Sorbate, Sodium Benzoate, Sodium Citrate, Sodium Gluconate, Sorbitan Caprylate, Sorbitan

Isostearate, Tocopherol, Vegetable Oil, Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Zinc Oxide 10%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)