Triderma Stubborn Diaper Rash™ Relief Cream

Triderma Stubborn Diaper Rash™ Relief Cream
SPL v5
SPL
SPL Set ID f8f3ae0b-aa55-4c2f-8823-54268524917b
Route
TOPICAL
Published
Effective Date 2019-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (1.5 g) Dimethicone (2 g)
Inactive Ingredients
Water Shea Butter Glycerin Glyceryl Stearate Se White Wax Cetostearyl Alcohol Safflower Oil Oatmeal Polysorbate 60 Polysorbate 80 Cetyl Esters Wax Zinc Pidolate Sodium Pyrrolidone Carboxylate Aloe Vera Leaf Dexpanthenol .alpha.-tocopherol Acetate Glyceryl Monostearate Sorbic Acid Hyaluronate Sodium Phytate Sodium Sodium Hydroxide Potassium Phosphate, Tribasic Xanthan Gum Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-31

Description

Allantoin 1.5% Dimethicone 2.0%

Purpose

Skin Protectant


Medication Information

Warnings and Precautions

Warnings For external use only

Do not use •on deep puncture wounds •on infections •on lacerations.

When using this product •avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if •condition worsens or does not improve within 7 days.

Indications and Usage

Uses •Helps treat and prevent diaper rash •Helps seal out wetness •Temporarily protects and helps relieve chafed, chapped or cracked skin

Purpose

Skin Protectant

Dosage and Administration

Directions  Change wet/soiled diapers promptly. Cleanse diaper area and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged.

Description

Allantoin 1.5% Dimethicone 2.0%

Section 42229-5

Helps treat & prevent diaper rash

Helps seal out wetness

Dermatologist Tested

This maximum strength cream works quickly to help relieve everyday or hard-to-heal, stubborn diaper rash.

Stubborn diaper rash can be result of changes in diet, medication, or prolonged wetness.

Made with essential botanicals, vitamins, AP4 ® Organic Aloe * Complex and clinically proven skin protectants, this soothing cream helps promote healing after the 1st use.

AP4 ® Organic Aloe* Complex - proprietary soothing botanical blend

Colloidal Oats - helps soothe & relieve irritated skin

Shea Butter - soothes & moisturizes

Beeswax - calming properties

Zinc PCA - additional healing

Also try:

Stubborn Eczema Itch™ Relief Cream

Aloe Healing & Cleansing Gel™

Daily Calming™ Moisturizer

Maximum Strength

Healing Botanicals

Stubborn Diaper Rash™ Relief Cream contains more healing power and is less sticky/gooey than most traditional diaper rash creams.

• Works quickly

• Soothes tender skin

• Helps prevent diaper rash from recurring

Non-Greasy • No Added Fragrance

Free from Cortisone, Steroids & Parabens

EXPERTS IN SKIN HEALING SINCE 1992

TriDerma MD ® provides healing solutions for irritated skin without harmful side effects.

It all began after one woman struggled to find safe and effective healing for her own skin problem.

This journey led to the creation of our proprietary AP4 ® Organic Aloe* Complex which is key to all our products.

QUALITY YOU CAN FEEL, RESULTS YOU CAN SEE. ®

Each product is made using this powerful complex plus nature’s best botanicals and clinically proven ingredients.

We are passionate in our pursuit to create fast healing products that work.

Learn More at www.triderma.com

MADE IN THE USA

Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879 ©2019 0919

Section 44425-7

Other information •Store at room temperature •Keep carton for important information.

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients: water, butyrospermum parkii (shea) butter, glycerin, glyceryl stearate SE, cera alba (beeswax), cetearyl alcohol, carthamus tinctorius (safflower) seed oil, avena sativa (oat) kernel flour, polysorbate 60, polysorbate 80, cetyl esters, zinc PCA, sodium PCA, aloe barbadensis leaf juice*, panthenol (pro-vitamin B5), tocopheryl acetate (vitamin E), glyceryl stearate, sorbic acid, sodium hyaluronate, sodium phytate, sodium hydroxide, cetyl potassium phosphate, xanthan gum, phenoxyethanol, ethylhexylglycerin. *Certified Organic Ingredient - Mayacert Certifier

Section 53413-1

Questions? 1-800-279-7282 M-F 8am-4pm PST

Packaging

Drug Facts

Active Ingredients

Allantoin 1.5%

Dimethicone 2.0%


Structured Label Content

Indications and Usage (34067-9)

Uses •Helps treat and prevent diaper rash •Helps seal out wetness •Temporarily protects and helps relieve chafed, chapped or cracked skin

Dosage and Administration (34068-7)

Directions  Change wet/soiled diapers promptly. Cleanse diaper area and allow to dry. Apply cream liberally as often as necessary with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged.

Warnings and Precautions (34071-1)

Warnings For external use only

Do not use •on deep puncture wounds •on infections •on lacerations.

When using this product •avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if •condition worsens or does not improve within 7 days.

Section 42229-5 (42229-5)

Helps treat & prevent diaper rash

Helps seal out wetness

Dermatologist Tested

This maximum strength cream works quickly to help relieve everyday or hard-to-heal, stubborn diaper rash.

Stubborn diaper rash can be result of changes in diet, medication, or prolonged wetness.

Made with essential botanicals, vitamins, AP4 ® Organic Aloe * Complex and clinically proven skin protectants, this soothing cream helps promote healing after the 1st use.

AP4 ® Organic Aloe* Complex - proprietary soothing botanical blend

Colloidal Oats - helps soothe & relieve irritated skin

Shea Butter - soothes & moisturizes

Beeswax - calming properties

Zinc PCA - additional healing

Also try:

Stubborn Eczema Itch™ Relief Cream

Aloe Healing & Cleansing Gel™

Daily Calming™ Moisturizer

Maximum Strength

Healing Botanicals

Stubborn Diaper Rash™ Relief Cream contains more healing power and is less sticky/gooey than most traditional diaper rash creams.

• Works quickly

• Soothes tender skin

• Helps prevent diaper rash from recurring

Non-Greasy • No Added Fragrance

Free from Cortisone, Steroids & Parabens

EXPERTS IN SKIN HEALING SINCE 1992

TriDerma MD ® provides healing solutions for irritated skin without harmful side effects.

It all began after one woman struggled to find safe and effective healing for her own skin problem.

This journey led to the creation of our proprietary AP4 ® Organic Aloe* Complex which is key to all our products.

QUALITY YOU CAN FEEL, RESULTS YOU CAN SEE. ®

Each product is made using this powerful complex plus nature’s best botanicals and clinically proven ingredients.

We are passionate in our pursuit to create fast healing products that work.

Learn More at www.triderma.com

MADE IN THE USA

Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879 ©2019 0919

Section 44425-7 (44425-7)

Other information •Store at room temperature •Keep carton for important information.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients: water, butyrospermum parkii (shea) butter, glycerin, glyceryl stearate SE, cera alba (beeswax), cetearyl alcohol, carthamus tinctorius (safflower) seed oil, avena sativa (oat) kernel flour, polysorbate 60, polysorbate 80, cetyl esters, zinc PCA, sodium PCA, aloe barbadensis leaf juice*, panthenol (pro-vitamin B5), tocopheryl acetate (vitamin E), glyceryl stearate, sorbic acid, sodium hyaluronate, sodium phytate, sodium hydroxide, cetyl potassium phosphate, xanthan gum, phenoxyethanol, ethylhexylglycerin. *Certified Organic Ingredient - Mayacert Certifier

Section 53413-1 (53413-1)

Questions? 1-800-279-7282 M-F 8am-4pm PST

Purpose

Skin Protectant

Packaging

Drug Facts

Active Ingredients (Active ingredients)

Allantoin 1.5%

Dimethicone 2.0%


Advanced Ingredient Data


Raw Label Data

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