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| Product NDC Code | 43479-105 | ||||
|---|---|---|---|---|---|
| Drug Name | Anti bac acne clearing |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 106309, 1541091 |
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| Application Number | M006 | ||||
| Labeler Name | KATE SOMERVILLE SKINCARE, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT BENZOYL PEROXIDE- 5%
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 CLEANSE SKIN THOROUGHLY BEFORE APPLYING. COVER THE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH 1 APPLICATION DAILY, THEN GRADUALLY INCREASE TO 2 OR 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCT APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USE OF PRODUCTS AND ASK A DOCTOR.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS WATER/AQUA/EAU, PPG-2 MYRISTYL ETHER PROPIONATE, ARGANIA SPINOSA KERNEL EXTRACT, PEG-40 STEARATE, SERENOA SERRULATA FRUIT EXTRACT, SESAMUM INDICUM (SESAME) SEED EXTRACT, ALCOHOL DENAT., SORBITAN STEARATE, HYDROGENATED METHYL ABEITATE, METHYL METHACRYLATE CROSSPOLYMER, CARBOMER, GLYCERYL STEARATE, CETYL ALCOHOL, TETRASODIUM EDTA, HYDROGENATED LECITHIN, CHOLESTEROL, CERAMIDE NS, CERAMIDE NP, OLEIC ACID, PALMITIC ACID, SODIUM ASCORBATE, SODIUM HYDROXIDE, EDTA, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL
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.USE FOR THE TREATMENT OF ACNE HELPS KEEP SKIN CLEAR 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.ANTI BAC ACNE CLEARING BENZOYL PEROXIDE WATER PPG-2 MYRISTYL ETHER PROPIONATE ARGANIA SPINOSA SEED PEG-40 STEARATE SAW PALMETTO SESAME SEED ALCOHOL SORBITAN MONOSTEARATE HYDROGENATED METHYL ABIETATE ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW) CARBOMER 940 GLYCERYL MONOSTEARATE CETYL ALCOHOL EDETATE SODIUM HYDROGENATED SOYBEAN LECITHIN CHOLESTEROL CERAMIDE 2 CERAMIDE 3 OLEIC ACID PALMITIC ACID SODIUM ASCORBATE SODIUM HYDROXIDE EDETIC ACID ETHYLHEXYLGLYCERIN PHENOXYETHANOL BENZOYL PEROXIDE BENZOYL PEROXIDE
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.0-UC_Anti-Bac_50mL
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 PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PT
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.STOP USE AND ASK A DOCTOR IF SKIN IRRITATION BECOMES SEVERE.
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 MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE 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. DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE. AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN. AVOID CONTACT WITH EYES, LIPS, AND MOUTH. AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT. SKIN IRRITATION MY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING, OR POSSIBLE SWELLING. IRRITATION MY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.
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