Activ O2 Acne Treatment Cream

Manufacturer
Activ Ozone (pty) Ltd
Effective date
2017-09-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:37

Label at a glance#

ProductActiv O2 Acne Treatment Cream
Active ingredientSULFUR
Label structure11 sections

Indications and 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.

Dosage and administration

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.

Storage and handling

• store below 25 °C

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur (10%)

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

•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

WARNINGS SECTION

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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

• store below 25 °C

Questions?

OTC - QUESTIONS SECTION

+1-917-676-2003

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

SPL UNCLASSIFIED SECTION

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
315220sulfur 10 % Topical CreamPSN1
315220sulfur 100 MG/ML Topical CreamSCD1
315220sulfur 10 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71577-222-502021-01-29C16284748780-1ba0f9c33-22d0-a910-e053-dadaa90a0b85ACTIV O2 ACNE TREATMENT CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71577-222-50Activ O2 Acne Treatment Cream1 in 1 CARTONCREAM11
71577-222-50Activ O2 Acne Treatment Cream50 mL in 1 JARCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71577-222ACTIV O2 ACNE TREATMENT CREAM (SULFUR) CREAM [ACTIV OZONE (PTY) LTD]1Legacy NDC, 2 package rows20171004_13948732-26b5-42a6-82b6-4318683d78c3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71577-22271577-222-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0fd1b938-1faf-424e-ac82-c8814ca5cdd413948732-26b5-42a6-82b6-4318683d78c32017-09-19WarningsExact identifier
spl id: 0fd1b938-1faf-424e-ac82-c8814ca5cdd4
spl set id: 13948732-26b5-42a6-82b6-4318683d78c3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.