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Product NDC Code | 10258-101 | ||||
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Drug Name | Oxygenetix oxygenating foundation acne control |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
RxCUI drug identifier | 103568 | ||||
Application Number | M006 | ||||
Labeler Name | COLONIAL DAMES CO LTD | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT: SALICYLIC ACID 2.0%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS: 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 BOTHERSOME DRYNESS OR PEELING OCCURS, THEN REDUCE THE FREQUENCY OF APPLICATION.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: ALOE BARBADENSIS GEL, ISODODECANE, TITANIUM DIOXIDE, METHICONE, POLYGLYCERYL-4 ISOSTEARATE, CETYL DIMETHICONE COPOLYOL, HEXYL LAURATE, CYCLOPENTASILOXANE, PEG/PPG-20/15 DIMETHICONE, SACCHAROMYCES CEREVISIAE, PEG-8, DIOCTYLDODECYL DODECANEDIOATE, IRON OXIDES, VITIS VINIFERA (GRAPE) SEED EXTRACT, GLYCERIN, O-CYMEN-5-OL, SILICA, CYCLOMETHICONE, DISTEARDIMONIUM HECTORITE, PROPYLENE CARBONATE, MARIS SAL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES: TREATS ACNE, HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES
Purpose
Information about the drug product’s indications for use.PURPOSE: ACNE TREATMENT
Spl product data elements
Usually a list of ingredients in a drug product.OXYGENETIX OXYGENATING FOUNDATION ACNE CONTROL SALICYLIC ACID ALOE VERA LEAF ISODODECANE TITANIUM DIOXIDE METHICONE (20 CST) POLYGLYCERYL-4 ISOSTEARATE CETYL DIMETHICONE 150 HEXYL LAURATE CYCLOMETHICONE 5 PEG/PPG-20/15 DIMETHICONE SACCHAROMYCES CEREVISIAE POLYETHYLENE GLYCOL 400 DIOCTYLDODECYL DODECANEDIOATE FERRIC OXIDE RED VITIS VINIFERA SEED GLYCERIN O-CYMEN-5-OL SILICON CYCLOMETHICONE DISTEARDIMONIUM HECTORITE PROPYLENE CARBONATE SEA SALT DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SALICYLIC ACID SALICYLIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Oxygetix Oxygenating Foundation Acne Control 15mL Label Image
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN: IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? CALL 1-888-500-1672 or EMAIL [email protected] VISIT HTTP://OXYGENETIX.COM
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.WHEN USING THIS PRODUCT: USING OTHER TOPICAL ACNE DRUGS AT THE SAME TIME 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.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION: KEEP TIGHTLY CLOSED, STORE AT 20-25°C (68-77°F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS: FOR EXTERNAL USE ONLY.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API