Soothion Acne Treatment Formula
FDA Label NDC 69031-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Electrolyzed Innovations, Llc for the product Soothion Acne Treatment Formula (NDC 69031-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Salicylic acid 1%

Purpose

Acne Treatment

Uses

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

Warnings

For external use only.

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding ask a doctor before use.

Otc - Keep Out Of Reach Of Children

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

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



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