FDA.reportPublic FDA data

ACTIV O2 ACNE TREATMENT CLEANSING BAR

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 CLEANSING BAR
Active ingredientSALICYLIC ACID
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, blackheads and whiteheads.

Dosage and administration

USE ONE TO THREE TIMES DAILY • wet your face or affected body parts with luke warm water, lather soap in hands. Massage lather onto skin with a gentle, circular motion for 20 to 30 seconds. Rinse thoroughly and gently pat dry. Follow with ACTIV O2 Acne Treatment Lotion or Cream. • avoid contact with eyes, lips and mouth

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 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, 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

USE ONE TO THREE TIMES DAILY

• wet your face or affected body parts with luke warm water, lather soap in hands. Massage lather onto skin with a gentle, circular motion for 20 to 30 seconds. Rinse thoroughly and gently pat dry. Follow with ACTIV O2 Acne Treatment Lotion or Cream. • avoid contact with eyes, lips and mouth

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylated Hydroxytoluene, Disodium Edetate, Glycerin, Jojoba (Simmondsia Chinensis) Seed Oil, Olive (Olea Europaea) Fruit Oil, Sodium Lauryl Sulphate, Sodium Palmitate, Sodium Palm Kernelate

Other information

STORAGE AND HANDLING SECTION

• store below 25 ​°C

Questions?

OTC - QUESTIONS SECTION

+1-917-676-2004 Available during working hours: (9am – 5pm) Monday to Friday

SPL UNCLASSIFIED SECTION

Manufactured by: ACTIV OZONE (Pty) Ltd.
77, 10th Road, Kew, Johannesburg, South Arica, 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
FRAGRANCE FREE

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312882salicylic acid 2 % Medicated Bar SoapPSN1
312882salicylic acid 0.02 MG/MG Medicated Bar SoapSCD1
312882salicylic acid 2 % Medicated Bar SoapSY1

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
71577-111-122021-01-29C16284748780-1ba0f9c33-0dde-a910-e053-dadaa90a0b85ACTIV O 2 ACNE TREATMENT CLEANSING BAR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71577-111-12ACTIV O2 ACNE TREATMENT CLEANSING BAR125 g in 1 CARTONSOAP1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71577-111ACTIV O2 ACNE TREATMENT CLEANSING BAR (SALICYLIC ACID) SOAP [ACTIV OZONE (PTY) LTD]1Legacy NDC, 1 package rows20171004_c7f618bd-1fcd-48b7-9e19-b2f9ce95bb7f.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71577-11171577-111-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
JOJOBA OIL724GKU717MIACT
OLIVE OIL6UYK2W1W1EIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PALMITATEJQ43KP6296IACT
SODIUM PALM KERNELATE6H91L1NXTWIACT

Source Document#

Source XML · Source PDF

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
b084dd3f-d59b-4e03-8ab5-4edc8b7d3e80c7f618bd-1fcd-48b7-9e19-b2f9ce95bb7f2017-09-18WarningsExact identifier
spl id: b084dd3f-d59b-4e03-8ab5-4edc8b7d3e80
spl set id: c7f618bd-1fcd-48b7-9e19-b2f9ce95bb7f

Reported adverse events (FAERS/openFDA)#

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