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

Purpose

Acne Treatment

Description

Salicylic acid 1%


Medication Information

Warnings

For external use only.

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

Acne Treatment

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



Inactive Ingredients

melaleuca alternifolia leaf, polyacrylic acid, water

Description
Manufactured for Electrolyzed Innovations, LLC

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

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





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.

Active Ingredient

Salicylic acid 1%

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

Warnings

For external use only.

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

Acne Treatment

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.
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

Description (34089-3)
Manufactured for Electrolyzed Innovations, LLC

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

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





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.

Active Ingredient (Active ingredient)

Salicylic acid 1%

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

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