ACTIV O2 ACNE TREATMENT LOTION

Manufacturer
Activ Ozone (pty) Ltd
Effective date
2017-09-18
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
Active ingredientSALICYLIC ACID
Label structure11 sections

Indications and 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

Dosage and administration

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

Storage and handling

Store below 25 ° C

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • 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

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.
  • skin irritation may occur such as redness, burning, itching and peeling. 

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

  • 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

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

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. 

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103568salicylic acid 2 % Topical LotionPSN1
103568salicylic acid 20 MG/ML Topical LotionSCD1
103568salicylic acid 2 % Topical LotionSY1

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
71577-333-752021-01-29C16284748780-1ba0f9c33-4b59-a910-e053-dadaa90a0b85ACTIV O2 ACNE TREATMENT LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71577-333-75Activ O2 Acne Treatment75 mL in 1 BOTTLELOTION751
71577-333-75Activ O2 Acne Treatment1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71577-333ACTIV O2 ACNE TREATMENT (SALICYLIC ACID) LOTION [ACTIV OZONE (PTY) LTD]1Legacy NDC, 2 package rows20171004_e3a0aed5-8392-452c-ab9b-af2b4ad25704.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
71577-33371577-333-75

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
a87aca13-e786-4f69-9f12-784e8cced06ee3a0aed5-8392-452c-ab9b-af2b4ad257042017-09-18WarningsExact identifier
spl id: a87aca13-e786-4f69-9f12-784e8cced06e
spl set id: e3a0aed5-8392-452c-ab9b-af2b4ad25704

Reported adverse events (FAERS/openFDA)#

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