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  5. Label Information: Activ O2 Acne Treatment Cream

FDA Label for Activ O2 Acne Treatment Cream

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 Cream 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



Sulfur (10%)


Purpose



Acne treatment


Uses



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


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 •avoid unnecessary sun exposure and use a sunscreen after using this product •skin irritation may occur such as redness, burning, itching and peeling •do not use on broken skin


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



USE ONE TO THREE TIMES DAILY

  • clean the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer 1 to 3 times a day.
  • if bothersome dryness or peeling occurs, reduce application to daily.

    • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.


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


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