theraplex®

theraplex®
SPL v1
SPL
SPL Set ID ff735ed1-10da-4fa2-b342-fd11eeec9059
Route
topical
Published
Effective Date 2019-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (1 g)
Inactive Ingredients
petrolatum cyclomethicone coconut oil microcrystalline wax ferulic acid oatmeal

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-08-15

Purpose

Anti-Itch

Description

Hydrocortisone 1%


Medication Information

Warnings

For external use only

• Do not use for the treatment of diaper rash, consult a doctor.

• When using this product, avoid contact with eyes.

• Stop use and ask a doctor if condition worsens, symptoms persist more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor.

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

•eczema •soaps •detergents •cosmetics •seborrheic dermatitis •psoriasis. •Other uses of this product should only be under the advice and supervision of a doctor.

Purpose

Anti-Itch

Directions

• Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

• Children under 2 years of age: do not use, ask a doctor.

Other Information

• Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

Petrolatum (special fraction), cyclomethicone, coconut oil, microcrystalline wax, ferulic acid, colloidal oatmeal

Description

Hydrocortisone 1%

Questions?

• Toll-free number 888-437-2753 • For more information on Eczema and Theraplex, visit us on our website at www.theraplex.com

Section 42229-5

NON STINGING

For Maximum Strength Relief of Rashes & Itching Flare-Ups Caused by

EczemaPsoriasisSeborrheic Dermatitis

NEW

Stops the itch of Eczema quickly

Helps repair and restore the skin’s natural protective barrier

Promotes healthy skin flora

Contains natural coconut oil to soothe and moisturize the skin

Instantly penetrates into the skin's surface

NO preservatives, parabens, fragrances, lanolin, or gluten

Not tested on animals

Non-stinging

Patent Pending

www.theraplex.com

Dist. By The Theraplex Company, LLC, Memphis, TN 38119

Section 50565-1

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

Packaging

Drug Facts

Active Ingredient

Hydrocortisone 1%


Structured Label Content

Warnings

For external use only

• Do not use for the treatment of diaper rash, consult a doctor.

• When using this product, avoid contact with eyes.

• Stop use and ask a doctor if condition worsens, symptoms persist more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor.

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

•eczema •soaps •detergents •cosmetics •seborrheic dermatitis •psoriasis. •Other uses of this product should only be under the advice and supervision of a doctor.

Purpose

Anti-Itch

Directions

• Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

• Children under 2 years of age: do not use, ask a doctor.

Other Information (Other information)

• Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

Petrolatum (special fraction), cyclomethicone, coconut oil, microcrystalline wax, ferulic acid, colloidal oatmeal

Questions?

• Toll-free number 888-437-2753 • For more information on Eczema and Theraplex, visit us on our website at www.theraplex.com

Section 42229-5 (42229-5)

NON STINGING

For Maximum Strength Relief of Rashes & Itching Flare-Ups Caused by

EczemaPsoriasisSeborrheic Dermatitis

NEW

Stops the itch of Eczema quickly

Helps repair and restore the skin’s natural protective barrier

Promotes healthy skin flora

Contains natural coconut oil to soothe and moisturize the skin

Instantly penetrates into the skin's surface

NO preservatives, parabens, fragrances, lanolin, or gluten

Not tested on animals

Non-stinging

Patent Pending

www.theraplex.com

Dist. By The Theraplex Company, LLC, Memphis, TN 38119

Section 50565-1 (50565-1)

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

Packaging

Drug Facts

Active Ingredient

Hydrocortisone 1%


Advanced Ingredient Data


Raw Label Data

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