Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 317ee6b7-995f-48c7-882c-a4a2f7938ae7
Route
TOPICAL
Published
Effective Date 2015-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 g)
Inactive Ingredients
Melaleuca Alternifolia Leaf Polyacrylic Acid (250000 Mw) Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-04-01

Description

Salicylic acid 1%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description
Manufactured for Electrolyzed Innovations, LLC

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

Uses
  • For the treatment of Acne.
  • Clears up acne pimples, blackheads and whiteheads and allows skin to heal.
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Section 53414-9

If pregnant or breast feeding ask a doctor before use.

Warnings

For external use only.

Directions
  • clean the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one to three times a daily.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two  or three times daily if needed or as directed by a doctor.

  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Active Ingredient

Salicylic acid 1%

Other Information
  • Store in a cool, dry place below 77°F
  • Protect from heat and light



Inactive Ingredients

melaleuca alternifolia leaf, polyacrylic acid, water

Principal Display Panel

Ion Infused



Acne Treatment Formula

Soothion

Ion Disperson Formula Designed to Clear Up

  • Acne

  • Pimples
  • Blemishes

  • Whiteheads
  • Blackheads

Net Wt. 8 oz (240 mL)              Made in USA





When Using This Product
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Structured Label Content

Uses
  • For the treatment of Acne.
  • Clears up acne pimples, blackheads and whiteheads and allows skin to heal.
Description (34089-3)
Manufactured for Electrolyzed Innovations, LLC

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Section 53414-9 (53414-9)

If pregnant or breast feeding ask a doctor before use.

Purpose

Acne Treatment

Warnings

For external use only.

Directions
  • clean the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one to three times a daily.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two  or three times daily if needed or as directed by a doctor.

  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Active Ingredient (Active ingredient)

Salicylic acid 1%

Other Information (Other information)
  • Store in a cool, dry place below 77°F
  • Protect from heat and light



Inactive Ingredients (Inactive ingredients)

melaleuca alternifolia leaf, polyacrylic acid, water

Principal Display Panel

Ion Infused



Acne Treatment Formula

Soothion

Ion Disperson Formula Designed to Clear Up

  • Acne

  • Pimples
  • Blemishes

  • Whiteheads
  • Blackheads

Net Wt. 8 oz (240 mL)              Made in USA





When Using This Product (When using this product)
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)