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  5. Label Information: Activ O2 Acne Treatment

FDA Label for Activ O2 Acne Treatment

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. INACTIVE INGREDIENTS
    9. OTHER INFORMATION
    10. QUESTIONS?
    11. OTHER
    12. PACKAGING

Activ O2 Acne Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Activ Ozone (pty) Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.