soraresal®

soraresal®
SPL v12
SPL
SPL Set ID af734362-057b-4011-bf4e-c4e4dd67f68c
Route
topical
Published
Effective Date 2024-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (2 g)
Inactive Ingredients
water safflower oil ficus benghalensis bark cassia fistula whole coconut oil glycerin glyceryl monostearate polysorbate 80 cetostearyl alcohol cetyl palmitate stearic acid cetyl alcohol trolamine phenoxyethanol dimethicone, unspecified butylated hydroxyanisole butylated hydroxytoluene

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-01-01

Purpose

Psoriasis

Description

Salicylic acid 2%


Medication Information

Warnings

For external use only.

Do not use

• on open wounds, infected or cracked skin.

• if you are sensitive or allergic to any of the ingredients used in this product.

Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product

• avoid contact with the eyes and if contact occurs, rinse eyes thoroughly with water.

• avoid contact with the mouth, genitals and mucous membranes.

• avoid direct sunlight after use.

Stop use and ask a doctor if

condition worsens or does not improve after regular use of this product as directed.

Purpose

Psoriasis

Directions

• gently apply a layer to affected areas one to three times daily or as directed by a doctor.

• please allow the cream to stay in contact with your skin for as much time as possible to have full absorption before reapplying.

Other Information

Store in a cool dark place at room temperature at 68°F - 77°F.

Inactive Ingredients

Water (Aqua), Safflower (Carthamus tinctorius) Seed, Banyan Tree (Ficus benghalensis) Bark, Golden Shower Tree (Cassia fistula) Whole plant, Coconut (Cocos nucifera) Oil, Glycerin, Glyceryl Monostearate, Polysorbate 80, Cetostearyl Alcohol, Cetyl Palmitate, Stearic Acid, Cetyl Alcohol, Triethanolamine, Phenoxyethanol, Dimethicone, Butylated Hydroxyanisole, Butylated Hydroxytoluene.

Description

Salicylic acid 2%

Use

for relief of the symptoms of psoriasis.

Section 42229-5

PSORIASIS CREAM

with 2% Salicylic Acid

• Comfort Remedy

• Tropical Plant Oils

• 100% Steroid-Free

• Advanced Formula

• Day and Night Care

• Essential Moisturizer

• Made by Biotechnology

Distributed by:

SUMMER HERBAL INC., 510 Saint Johns Court,

Oak Brook, IL 60523

You may report serious side effects to the above U.S. address.

PRODUCT OF INDIA

Soraresal Cream relieves itching, calms irritation and removes scales, as gentle care for psoriasis. The active ingredient of 2% salicylic acid can reduce psoriasis symptoms. Sustainably harvested plants moisturize the skin with natural oils. Help treat psoriasis with Soraresal.

Manufactured for:

Atrimed Pharmaceuticals Pvt. Ltd.

Manufactured by:

BioMylz Pvt. Ltd.

at Building No. 1, # 21-D, 2nd Phase

Peenya Industrial Area

Bangalore, Karnataka 560058, India

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

Salicylic acid 2%

Questions Or Comments?

1-800-743-1718

Mon-Fri 9:00 A.M. - 5:00 P.M.


Structured Label Content

Warnings

For external use only.

Do not use

• on open wounds, infected or cracked skin.

• if you are sensitive or allergic to any of the ingredients used in this product.

Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product

• avoid contact with the eyes and if contact occurs, rinse eyes thoroughly with water.

• avoid contact with the mouth, genitals and mucous membranes.

• avoid direct sunlight after use.

Stop use and ask a doctor if

condition worsens or does not improve after regular use of this product as directed.

Purpose

Psoriasis

Directions

• gently apply a layer to affected areas one to three times daily or as directed by a doctor.

• please allow the cream to stay in contact with your skin for as much time as possible to have full absorption before reapplying.

Other Information (Other information)

Store in a cool dark place at room temperature at 68°F - 77°F.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Safflower (Carthamus tinctorius) Seed, Banyan Tree (Ficus benghalensis) Bark, Golden Shower Tree (Cassia fistula) Whole plant, Coconut (Cocos nucifera) Oil, Glycerin, Glyceryl Monostearate, Polysorbate 80, Cetostearyl Alcohol, Cetyl Palmitate, Stearic Acid, Cetyl Alcohol, Triethanolamine, Phenoxyethanol, Dimethicone, Butylated Hydroxyanisole, Butylated Hydroxytoluene.

Use

for relief of the symptoms of psoriasis.

Section 42229-5 (42229-5)

PSORIASIS CREAM

with 2% Salicylic Acid

• Comfort Remedy

• Tropical Plant Oils

• 100% Steroid-Free

• Advanced Formula

• Day and Night Care

• Essential Moisturizer

• Made by Biotechnology

Distributed by:

SUMMER HERBAL INC., 510 Saint Johns Court,

Oak Brook, IL 60523

You may report serious side effects to the above U.S. address.

PRODUCT OF INDIA

Soraresal Cream relieves itching, calms irritation and removes scales, as gentle care for psoriasis. The active ingredient of 2% salicylic acid can reduce psoriasis symptoms. Sustainably harvested plants moisturize the skin with natural oils. Help treat psoriasis with Soraresal.

Manufactured for:

Atrimed Pharmaceuticals Pvt. Ltd.

Manufactured by:

BioMylz Pvt. Ltd.

at Building No. 1, # 21-D, 2nd Phase

Peenya Industrial Area

Bangalore, Karnataka 560058, India

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 (Active ingredient)

Salicylic acid 2%

Questions Or Comments? (Questions or comments?)

1-800-743-1718

Mon-Fri 9:00 A.M. - 5:00 P.M.


Advanced Ingredient Data


Raw Label Data

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