drug facts

drug facts
SPL v2
SPL
SPL Set ID b64d3b37-4242-4779-9a47-957b04ff384d
Route
topical
Published
Effective Date 2015-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (2 g)
Inactive Ingredients
arnica montana flower calendula officinalis flower cannabis sativa seed oil horse chestnut imidurea sheanut oil spearmint oil stearic acid water

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2015-04-01

Purpose

Psoriasis / Seborrheic Dermatitis

Description

Salicylic Acid 2%


Medication Information

Warnings

For external use only.

Uses
Controls and helps eliminate recurrence of:
  • skin itching
  • irritation
  • redness
  • flaking and scaling associated with psoriasis and seborrheic dermatitis.
Purpose

Psoriasis / Seborrheic Dermatitis

Directions
  • apply to affected areas one to four times daily or as directed by a doctor.
Other Information
  • Store in a cool, dry place below 77°F
  • Protect from heat and light



Inactive Ingredients

arnica montana flower, calendula officinalis flower, cannabis sativa seed oil, emulsifying wax, horse chestnut, imidazolidinyl urea, sheanut oil, spearmint oil, stearic acid, water

Description


Manufactured for Electrolyzed Innovations, LLC

(866) 528-3721   2214 Wilshire Dr, Piqua, OH 45356 USA

Principal Display Panel



Psoriasis and Seborrheic Dermatitis Formula

Soothion

Ion Dispersion Formula Designed to Relieve

  • Itching
  • Redness
  • Irritation

  • Flaking
  • Scaling



Net Wt. 8 oz ( 226 g )                  Made in USA

Section 50565-1

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

Section 53414-9

If pregnant or breast feeding ask a doctor before use.

Active Ingredient

Salicylic Acid 2%

Ask A Doctor Before Use
  • if condition covers a large area of the body.
When Using This Product
  • avoid contact with the eyes. If contact occurs rinse eyes thoroughly with water.
Stop Use and Ask A Doctor If
  • condition worsens or does not improve after regular use of this product as directed.

Structured Label Content

Warnings

For external use only.

Uses
Controls and helps eliminate recurrence of:
  • skin itching
  • irritation
  • redness
  • flaking and scaling associated with psoriasis and seborrheic dermatitis.
Purpose

Psoriasis / Seborrheic Dermatitis

Directions
  • apply to affected areas one to four times daily or as directed by a doctor.
Other Information (Other information)
  • Store in a cool, dry place below 77°F
  • Protect from heat and light



Inactive Ingredients (Inactive ingredients)

arnica montana flower, calendula officinalis flower, cannabis sativa seed oil, emulsifying wax, horse chestnut, imidazolidinyl urea, sheanut oil, spearmint oil, stearic acid, water

Description (34089-3)


Manufactured for Electrolyzed Innovations, LLC

(866) 528-3721   2214 Wilshire Dr, Piqua, OH 45356 USA

Principal Display Panel



Psoriasis and Seborrheic Dermatitis Formula

Soothion

Ion Dispersion Formula Designed to Relieve

  • Itching
  • Redness
  • Irritation

  • Flaking
  • Scaling



Net Wt. 8 oz ( 226 g )                  Made in USA

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

If pregnant or breast feeding ask a doctor before use.

Active Ingredient (Active ingredient)

Salicylic Acid 2%

Ask A Doctor Before Use (Ask a doctor before use)
  • if condition covers a large area of the body.
When Using This Product (When using this product)
  • avoid contact with the eyes. If contact occurs rinse eyes thoroughly with water.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or does not improve after regular use of this product as directed.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)