Activ O2 Acne Treatment
FDA Label NDC 71577-333

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Activ Ozone (pty) Ltd for the product Activ O2 Acne Treatment (NDC 71577-333). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Salicylic acid 2%

Purpose

Acne treatment

Uses

  • for the treatment of acne
  • clears up acne blemishes, acne pimples, blackheads, whiteheads and allows skin to heal 
  • helps prevent the development of new acne pimples blackheads and whiteheads

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. 
  • avoid contact with the eyes, lips and mouth.
  • skin irritation may occur such as redness, burning, itching and peeling. 

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a 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 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

Inactive Ingredients

Cetearyl Alcohol, Disodium EDTA, Ethylhexyl Cocoate, Fragrance (Parfum), Jojoba (Simmondsia Chinensis) Seed Oil, Olive (Olea Europaea) Fruit Oil, Phenoxyethanol, Polysorbate 20, Potassium Cetyl Phosphate, PPG-3 Benzyl Ether Myristate, Sodium Polyacrylate, Water (Aqua)

Other Information

Store below 25 °C

Questions?

+1-917-676-2003

Available during working hours:

(9am - 5pm)

Monday to Friday

Other

Manufactured by:

ACTIV OZONE (Pty) Ltd.

77, 10th Road, Kew, 

Johannesburg, 

South Africa, 2090. 

Tel: +27-11-887-1752

www.activo2.com

Made in South Africa

Distributed / Imported / Marketed by:

Miller Methods Imports

3921 Alton Road,

Miami Beach FL, 33140

You may report serious side effects to the above address

INSPIRED BY NATURE

PERFECTED BY SCIENCE

ADVANCED SCIENTIFIC FORMULATION

WITH ACTIVE OZONE TECHNOLOGY

Performs skin clearing action

Based on organic ozonised plant oils.

Apply one to three times daily.

First wash face with ACTIV O2 Acne Treatment Cleansing Bar then apply the lotion thinly onto the affected areas. Gently massage in small circles.

Avoid the eye area.

Provides effective relief from acne and blemishes and helps prevent the development of new acne blemishes, acne pimples, blackheads and whiteheads. 

* Please review the disclaimer below.