FDA.reportPublic FDA data

OXYGENETIX - OXYGENATING HYDRO-MATRIX

Manufacturer
COLONIAL DAMES CO LTD
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:17:40

Label at a glance#

ProductOXYGENETIX - OXYGENATING HYDRO-MATRIX ACNE CONTROL
Active ingredientSALICYLIC ACID
Label structure11 sections

Indications and uses

TREATS ACNE, HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES

Dosage and administration

BEFORE USE CLEANSE SKIN THOROUGHLY AND PAT DRY. APPLY BY COVERING THE ENTIRE AFFECTED AREA WITH ONE APPLICATION. ONLY IF NEEDED YOU CAN GRADUALLY INCREASE TO 2 OR 3 TIMES DAILY OR AS DIRECTED BY A DOCTOR. IF IRRITATING DRYNESS OR PEELING OCCURS, REDUCE THE FREQUENCY OF APPLICATION.

Storage and handling

KEEP TIGHTLY CLOSED, STORE AT 20-25°C (68-77°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

SALICYLIC ACID 2%

PURPOSE:

OTC - PURPOSE SECTION

ACNE TREATMENT

USES:

INDICATIONS & USAGE SECTION

TREATS ACNE, HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES

WARNINGS:

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT:

OTC - WHEN USING SECTION

USING OTHER TOPICAL ACNE DRUGS COMBINED WITH OR RIGHT AFTER USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

BEFORE USE CLEANSE SKIN THOROUGHLY AND PAT DRY. APPLY BY COVERING THE ENTIRE AFFECTED AREA WITH ONE APPLICATION. ONLY IF NEEDED YOU CAN GRADUALLY INCREASE TO 2 OR 3 TIMES DAILY OR AS DIRECTED BY A DOCTOR. IF IRRITATING DRYNESS OR PEELING OCCURS, REDUCE THE FREQUENCY OF APPLICATION.

OTHER INFORMATION:

STORAGE AND HANDLING SECTION

KEEP TIGHTLY CLOSED, STORE AT 20-25°C (68-77°F)

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS GEL, GLYCERYLSTEARATE, SODIUM HYALURONATE, CETYL ESTERS, DECYL OLEATE, SACCHAROMYCES CEREVISIAE EXTRACT, STEARIC ACID, SODIUM PCA, VITUS VIN I FERA (GRAPE SEED) EXTRACT, TRIETHANOLAMINE, GLYCERIN, TOCOPHERYL ACETATE (VITAMIN E), LECITHIN, SALIX ALBA (WILLOW) EXTRACT, CETANOL, PEG-100 STEARATE, POTASSIUM SORBATE, O-CYMEN-5-0L, GREEN TEA EXTRACT.

QUESTIONS...

OTC - QUESTIONS SECTION

CALL: 1-888-500-1672
EMAIL: INFO@OXYGENETIX.COM
VISIT: OXYGENETIX.COM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oxygenetix

Oxygenating Hydro-Matrix

Acne Control

75mL

Label ImageLabel Image

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10258-103OXYGENETIX - OXYGENATING HYDRO-MATRIX ACNE CONTROL (SALICYLIC ACID) LOTION [COLONIAL DAMES CO LTD]2Unmatched20231219_0c92d0b3-176b-de2d-e063-6394a90a34d1.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10258-10310258-103-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ESTERS WAXD072FFP9GUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETYL ALCOHOL936JST6JCNIACT
HYALURONATE SODIUMYSE9PPT4THIACT
TROLAMINE9O3K93S3TKIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SALIX ALBA BARK205MXS71H7IACT
ALOE VERA LEAFZY81Z83H0XIACT
SACCHAROMYCES CEREVISIAE978D8U419HIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
GLYCERINPDC6A3C0OXIACT
O-CYMEN-5-OLH41B6Q1I9LIACT
SALICYLIC ACIDO414PZ4LPZACTIB
STEARIC ACID4ELV7Z65APIACT
PEG-100 STEARATEYD01N1999RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
DECYL OLEATEZGR06DO97TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
LECITHIN, SOYBEAN1DI56QDM62IACT

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
0cd28fbd-519c-1fa8-e063-6294a90aa17a0c92d0b3-176b-de2d-e063-6394a90a34d12023-12-31WarningsExact identifier
spl id: 0cd28fbd-519c-1fa8-e063-6294a90aa17a
spl set id: 0c92d0b3-176b-de2d-e063-6394a90a34d1

Reported adverse events (FAERS/openFDA)#

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