SPL v3
SPL
SPL Set ID 03739345-2ed2-4157-89e7-48926721815b
Route
TOPICAL
Published
Effective Date 2023-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Mineral Oil Cetyl Alcohol Butylene Glycol Stearic Acid Sodium Citrate Glyceryl Stearate Citrate Trolamine Peg-100 Stearate Polysorbate 60 Phenoxyethanol Carbomer 934 Zinc Pidolate Panthenol Camellia Oleifera Leaf Artemisia Vulgaris Root Glycyrrhizinate Dipotassium Edetate Disodium Methylparaben Propylparaben Rheum Palmatum Root Rosa Damascena Flower Citric Acid Monohydrate Dimethicone Olive Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-09-01

Description

Salicylic Acid -2%

Purpose

Psoriasis and seborrheic dermatitis


Medication Information

Purpose

Psoriasis and seborrheic dermatitis

Description

Salicylic Acid -2%

Uses

Relieves and helps prevent recurrence of

  • itching
  • irration
  • redness
  • flaking and scaling due to psoriasis and seborrheic dermatitis
Section 50565-1

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

Purposes

Psoriasis and seborrheic dermatitis

Warnings

For external use only

Ask A doctor before use if condition covers a large area of the body.

When using this product avoid contact with eyes. if contact occurs, rinse throughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use.

Directions

Apply to affected areas one to four times daily or as directed by a doctor.

Active Ingredient

Salicylic Acid -2%

Other Information

store at a controlled room temperature 68°-77°F ( 20°- 25°C)

Questions? 1-800-222-1087

Inactive Ingredients

Purifed Water, Caprylic/Capric Triglyceride, Mineral Oil, Cetyl Alcohol, Butylene Glycol, Stearic Acid, Sodium Citrate, Glyceral Stearate, Triethanolamine, PEG-100 Sterate, Polysorbate 60 , Phenoxyethanol, Carbomer, Zinc PCA, Panthenol, Camellia Oleifera leaf extract , Algea Extract, Artemisia Vulgaris Extract, Dipotassium Glycyrrhizate, Disodium EDTA, Rheum Palmatum Extract, Rosa Damascena Extract, Citric Acid, Methylparaben, Propylparaben, Dimethicone, Extra Virign Olea Europaea( Olive) Fruit oil

Principal Display Panel 1 Oz. Tube

Sheffield Pharmaceuticals NDC 11527-478-64

PSORIASIS

Salicylic Acid 2%

edicated Moisturizer

Made in the USA

NET WT 1 oz. ( 28g)

Principal Display Panel Carton 1.0 Oz

Sheffield Pharmaceuticals NDC 11527-478-64

PSORIASIS

Salicylic Acid 2%

edicated Moisturizer

Made in the USA

NET WT 1 oz. ( 28g)


Structured Label Content

Uses

Relieves and helps prevent recurrence of

  • itching
  • irration
  • redness
  • flaking and scaling due to psoriasis and seborrheic dermatitis
Section 50565-1 (50565-1)

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

Purposes

Psoriasis and seborrheic dermatitis

Warnings

For external use only

Ask A doctor before use if condition covers a large area of the body.

When using this product avoid contact with eyes. if contact occurs, rinse throughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use.

Directions

Apply to affected areas one to four times daily or as directed by a doctor.

Active Ingredient

Salicylic Acid -2%

Other Information (Other information)

store at a controlled room temperature 68°-77°F ( 20°- 25°C)

Questions? 1-800-222-1087

Inactive Ingredients (Inactive ingredients)

Purifed Water, Caprylic/Capric Triglyceride, Mineral Oil, Cetyl Alcohol, Butylene Glycol, Stearic Acid, Sodium Citrate, Glyceral Stearate, Triethanolamine, PEG-100 Sterate, Polysorbate 60 , Phenoxyethanol, Carbomer, Zinc PCA, Panthenol, Camellia Oleifera leaf extract , Algea Extract, Artemisia Vulgaris Extract, Dipotassium Glycyrrhizate, Disodium EDTA, Rheum Palmatum Extract, Rosa Damascena Extract, Citric Acid, Methylparaben, Propylparaben, Dimethicone, Extra Virign Olea Europaea( Olive) Fruit oil

Principal Display Panel 1 Oz. Tube (Principal Display Panel 1 oz. - Tube)

Sheffield Pharmaceuticals NDC 11527-478-64

PSORIASIS

Salicylic Acid 2%

edicated Moisturizer

Made in the USA

NET WT 1 oz. ( 28g)

Principal Display Panel Carton 1.0 Oz (Principal Display Panel - Carton 1.0 oz)

Sheffield Pharmaceuticals NDC 11527-478-64

PSORIASIS

Salicylic Acid 2%

edicated Moisturizer

Made in the USA

NET WT 1 oz. ( 28g)


Advanced Ingredient Data


Raw Label Data

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