84746-001 update

84746-001 update
SPL v2
SPL
SPL Set ID 22752a52-463f-9316-e063-6394a90a1f28
Route
topical
Published
Effective Date 2024-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (3 g)
Inactive Ingredients
smilax glabra whole sophora flavescens whole water artemisia argyi leaf cnidium monnieri whole dictamnus dasycarpus root phellodendron amurense whole solidago decurrens whole

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-19

Purpose

Seborrheic dermatitis & Psoriasis

Description

Salicylic Acid 3%


Medication Information

Warnings

"Forexternaluse only. " Ask adoctor before use if you are allergic to ingredients inthis product, " When using this product avoid

contact with eyes.lf contact occurs, rinse the eyesthoroughly with water. " Stop use and ask a doctorif condition worsens or does not improve afterreqular use as directed.. Keep out ofreach ofchildren. lf swallowed, get medical help or contact aPoison Control Center (1-800-222-1222) right away.

Purpose

Seborrheic dermatitis & Psoriasis

Directions

Apply a small amount to theproblem areas with circular motions for 3 minutes tillthe skin absorbs the cream." Apply it 2-3 times aday for the best result. " Continue to use for 3-5 daysafter symptoms resolve to prevent a recurrence.Do not use it on pregnant women & children under12 years of age unless directed by a doctor.

Other Information

Store at room temperatureand out of direct sunlight

Inactive Ingredients

Water (Aqua), Artemisiaextracts, Sophora Flavescens, Cnidium Monnieri (L.)CussKochia scoparia, Dictamni Cortex, Smilax Glabra Roxb,Solidago Decurrens, Phellodendron amurense Ruprecht,

Description

Salicylic Acid 3%

Principal Display Panel

Use

Relieves and helps prevent recurrence of skin and/or scalp: itching, flaking, scaling, redness, and irritationassociated with psoriasis and seborrheic dermatitis.

Stop Use

When using this product avoid

contact with eyes.lf contact occurs, rinse the eyesthoroughly with water. " Stop use and ask a doctorif condition worsens or does not improve afterreqular use as directed.

Questions

Visit www.roycederm.com

Ask Doctor

Ask adoctor before use if you are allergic to ingredients inthis product

Do Not Use

Do not use it on pregnant women & children under12 years of age unless directed by a doctor.

When Using

Forexternaluse only.

Active Ingredient

Salicylic Acid 3%

Keep Oot of Reach of Children

Keep out ofreach ofchildren


Structured Label Content

Warnings

"Forexternaluse only. " Ask adoctor before use if you are allergic to ingredients inthis product, " When using this product avoid

contact with eyes.lf contact occurs, rinse the eyesthoroughly with water. " Stop use and ask a doctorif condition worsens or does not improve afterreqular use as directed.. Keep out ofreach ofchildren. lf swallowed, get medical help or contact aPoison Control Center (1-800-222-1222) right away.

Purpose

Seborrheic dermatitis & Psoriasis

Directions

Apply a small amount to theproblem areas with circular motions for 3 minutes tillthe skin absorbs the cream." Apply it 2-3 times aday for the best result. " Continue to use for 3-5 daysafter symptoms resolve to prevent a recurrence.Do not use it on pregnant women & children under12 years of age unless directed by a doctor.

Other Information (Other information)

Store at room temperatureand out of direct sunlight

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Artemisiaextracts, Sophora Flavescens, Cnidium Monnieri (L.)CussKochia scoparia, Dictamni Cortex, Smilax Glabra Roxb,Solidago Decurrens, Phellodendron amurense Ruprecht,

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

Relieves and helps prevent recurrence of skin and/or scalp: itching, flaking, scaling, redness, and irritationassociated with psoriasis and seborrheic dermatitis.

Stop Use

When using this product avoid

contact with eyes.lf contact occurs, rinse the eyesthoroughly with water. " Stop use and ask a doctorif condition worsens or does not improve afterreqular use as directed.

Questions

Visit www.roycederm.com

Ask Doctor

Ask adoctor before use if you are allergic to ingredients inthis product

Do Not Use (Do not use)

Do not use it on pregnant women & children under12 years of age unless directed by a doctor.

When Using

Forexternaluse only.

Active Ingredient

Salicylic Acid 3%

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out ofreach ofchildren


Advanced Ingredient Data


Raw Label Data

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