84746-002

84746-002
SPL v1
SPL
SPL Set ID 227562fb-885b-dab3-e063-6394a90ab3bb
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
Fragrance 13576 Coco Monoethanolamide Citric Acid Monohydrate Coptis Teeta Root Stemona Tuberosa Whole Cnidium Monnieri Whole Borneol Menthol Fallopia Multiflora Root Sauromatum Giganteum Whole Bassia Scoparia Whole Guar Gum Glycol Cetearate Artemisia Argyi Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-19

Description

Salicylic acid 3%

Purpose

Seborrheic dermatitis and psoriasis.


Medication Information

Purpose

Seborrheic dermatitis and psoriasis.

Description

Salicylic acid 3%

Use

Relieves and helps prevent recurrence of scalp: itching, flaking, scaling, redness and irritation associated with psoriasis and seborrheic dermatitis.

Stop Use

if conditionworsens or does not improve afterregular use as directed

Warnings

For external use only.

Questions

Visit www.roycederm.com

Ask Doctor

if you areallergic to ingredients in this product

Directions

Apply shampoo & massage into the scalp,Leave in hair for 3-5 minutes to allow maximum absorption.Rinse and repeat as needed,Use daily for best results.Do not use it on children under 12 years of age unless directed by a doctor.

Do Not Use

Do not use it on children under 12 years of age unless directed by a doctor.

When Using

avoid contacwith eyes. lf contact occurs, rinse theeyes thoroughly with water.

Active Ingredient

Salicylic acid 3%

Other Information

Store at room temperature and out of direct sunlight

Inactive Ingredients

Water (Agua), Artemisia Extract, Fleeceflower Root, Cnidium Monnieri, Kochia Scoparia Gleditsia Sinensis, Typhonium Giganteum Eng, Stemona Tuberosa, Rhizoma Smilacis Glabrae, Borneol, Menthol, Fragrance,Cocamide MEA, Citric Acid, Guar Gum,Ethylene Glycol Stearate

Principal Display Panel

Keep Oot of Reach of Children

Do not use it on children under 12 years of age unless directed by a doctor.


Structured Label Content

Use

Relieves and helps prevent recurrence of scalp: itching, flaking, scaling, redness and irritation associated with psoriasis and seborrheic dermatitis.

Purpose

Seborrheic dermatitis and psoriasis.

Stop Use

if conditionworsens or does not improve afterregular use as directed

Warnings

For external use only.

Questions

Visit www.roycederm.com

Ask Doctor

if you areallergic to ingredients in this product

Directions

Apply shampoo & massage into the scalp,Leave in hair for 3-5 minutes to allow maximum absorption.Rinse and repeat as needed,Use daily for best results.Do not use it on children under 12 years of age unless directed by a doctor.

Do Not Use (Do not use)

Do not use it on children under 12 years of age unless directed by a doctor.

When Using

avoid contacwith eyes. lf contact occurs, rinse theeyes thoroughly with water.

Active Ingredient

Salicylic acid 3%

Other Information (Other information)

Store at room temperature and out of direct sunlight

Inactive Ingredients (Inactive ingredients)

Water (Agua), Artemisia Extract, Fleeceflower Root, Cnidium Monnieri, Kochia Scoparia Gleditsia Sinensis, Typhonium Giganteum Eng, Stemona Tuberosa, Rhizoma Smilacis Glabrae, Borneol, Menthol, Fragrance,Cocamide MEA, Citric Acid, Guar Gum,Ethylene Glycol Stearate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Do not use it on children under 12 years of age unless directed by a doctor.


Advanced Ingredient Data


Raw Label Data

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