SORARESAL- salicylic acid cream

SORARESAL by

Drug Labeling and Warnings

SORARESAL by is a Otc medication manufactured, distributed, or labeled by Summer Herbal Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Psoriasis

Use

for relief of the symptoms of psoriasis.

Warnings

For external use only.

Do not use

on open wounds, nor infected, 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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 68°F.

Inactive ingredients

Water (Aqua), Safflower (Carthamus tinctorius) Seed Oil, Banyan Tree (Ficus benghalensis) Bark Extract, Golden Shower Tree (Cassia fistula) Fruit Extract, Glyceryl Monostearate, Glycerin, Stearic Acid, Cetyl Palmitate, Polysorbate 80, Cetostearyl Alcohol, PEG-100 Stearate, Cetyl Alcohol, Coconut (Cocos nucifera) Oil, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin, Dimethicone, Butylated Hydroxyanisole, Butylated Hydroxytoluene.

Questions or comments?

1-800-743-1718

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

SPL UNCLASSIFIED SECTION

PSORIASIS CREAM

Relieves Itching

Calms Irritation

Reduces Scaling

Dermo-Cosmetic

100% Steroid-Free

Fragrance-Free

Distributed by:

SUMMER HERBAL INC., 150N Michigan Ave,

Suite 2800, Chicago, IL 60601

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

PRODUCT OF INDIA

SORARESAL CREAM relieves itching, calms irritation and reduces scaling for easy relief from psoriasis. The active ingredient of 2% Salicylic Acid effectively treats and makes your skin clear. Special plants of the tropical rainforest beautify and moisturize your skin with powerful oils that are so rare. Control psoriasis easily with SORARESAL CREAM.

Mfg.Lic.No.:KTK/32A/47/2013

Manufactured by:

Atrimed Pharmaceuticals Pvt. Ltd.

at Plot No. 41. KIADB Industrial Area

Malur, Kolar, Karnataka - 563130

India 

Packaging

INGREDIENTS AND APPEARANCE

SORARESAL 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73526-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SAFFLOWER OIL (UNII: 65UEH262IS)
FICUS BENGHALENSIS BARK (UNII: S7NJY6RN0N)
CASSIA FISTULA FRUIT (UNII: J65X53KM9E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCONUT OIL (UNII: Q9L0O73W7L)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73526-002-06	1 in 1 BOX	01/01/2020
1		191 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/01/2020

Labeler - Summer Herbal Inc. (053442867)