Activ O2 Acne Treatment Cream

Activ O2 Acne Treatment Cream
SPL v1
SPL
SPL Set ID 13948732-26b5-42a6-82b6-4318683d78c3
Route
TOPICAL
Published
Effective Date 2017-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (10 g)
Inactive Ingredients
Cetostearyl Alcohol Edetate Disodium Anhydrous Ethylhexyl Cocoate Jojoba Oil Olive Oil Phenoxyethanol Polysorbate 20 Potassium Cetyl Phosphate Ppg-3 Benzyl Ether Myristate Sodium Polyacrylate (8000 Mw) Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-09-27

Description

Sulfur (10%)

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Sulfur (10%)

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.

Section 42229-5

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

Section 50565-1

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

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

Packaging

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.

Drug Facts

Questions?

+1-917-676-2003

Available during working hours: (9am - 5pm)  Monday to Friday

Active Ingredient

Sulfur (10%)

Other Information

• store below 25 °C

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)


Structured Label Content

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.

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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

Purpose

Acne treatment

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

Packaging

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.

Drug Facts

Questions?

+1-917-676-2003

Available during working hours: (9am - 5pm)  Monday to Friday

Active Ingredient (Active ingredient)

Sulfur (10%)

Other Information (Other information)

• store below 25 °C

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)


Advanced Ingredient Data


Raw Label Data

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