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| Product NDC Code | 49527-117 | ||||||||
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| Drug Name | Acne solutions all-over clearing treatment |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| RxCUI drug identifier | 200009 | ||||||||
| Application Number | M006 | ||||||||
| Labeler Name | CLINIQUE LABORATORIES 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 2.5%
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 DIRECTIONS: CLEANS 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 DOY OR EVERY OTHER DAY IF GOING OUTSIDE, USE A SUNSCREEN AFTER APPLYING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, DISCONTINUE USE OF BOTH PRODUCTS AND CONSULT A DOCTOR FOR BEST RESULTS, USE AFTER ACNE SOLUTIONS CLEANSING FOAM AND CLARIFYING LOTION
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water\aqua\eau∙cyclopentasiloxane∙butylene glycol∙cyclohexasiloxane∙ceteareth-20∙dimethicone∙sucrose∙camellia sinensis (green tea) leaf extract∙hordeum vulgare (barley) extract\extrait d'orge∙acetyl glucosamine∙lactobacillus ferment∙poria cocos sclerotium extract∙polymethyl methacrylate∙laminaria saccharina extract∙gentiana lutea (gentian) root extract∙astrocaryum murumuru seed butter∙acrylamide/sodium acryloyldimethyltaurate copolymer∙myristyl alcohol∙glycerin∙zeolite∙algae extract∙linoleic acid∙10-hydroxydecanoic acid∙cucumis sativus (cucumber) fruit extract∙caffeine∙ cholesterol∙tocopheryl acetate∙bisabolol∙polysorbate 80∙sodium hyaluronate∙propylene glycol dicaprate∙capryloyl glycine∙helianthus annuus (sunflower) seed extract∙quaternium-22∙caprylyl glycol∙isohexadecane∙xanthan gum∙disodiumedta∙chloroxylenol∙phenoxyethanol∙titanium dioxide (ci 77891) [iln47611]
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 Clears acne blemishes 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.ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT BENZOYL PEROXIDE BUTYLENE GLYCOL DIMETHICONE ASTROCARYUM MURUMURU SEED BUTTER GLYCERIN CHOLESTEROL XANTHAN GUM SUCROSE BARLEY GLUCOSAMINE GENTIANA LUTEA ROOT SACCHAROMYCES LYSATE MYRISTYL ALCOHOL LINOLEIC ACID CUCUMBER .ALPHA.-TOCOPHEROL ACETATE, DL- HYALURONATE SODIUM CAPRYLYL GLYCOL EDETATE DISODIUM PHENOXYETHANOL WATER CYCLOMETHICONE 5 CYCLOMETHICONE 6 POLYOXYL 20 CETOSTEARYL ETHER GREEN TEA LEAF LIMOSILACTOBACILLUS REUTERI FU LING POLY(METHYL METHACRYLATE; 450000 MW) ACRYLAMIDOPROPYLTRIMONIUM CHLORIDE/ACRYLAMIDE COPOLYMER (400 MPA.S) ZEOLITE A AGAR, UNSPECIFIED 10-HYDROXYDECANOIC ACID CAFFEINE .ALPHA.-BISABOLOL, (+)- POLYSORBATE 80 PROPYLENE GLYCOL DICAPRATE CAPRYLOYL GLYCINE SUNFLOWER SEED QUATERNIUM-22 ISOHEXADECANE CHLOROXYLENOL TITANIUM DIOXIDE 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.PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton CLINIQUE acne solutions all-over clearing treatment oil-free STEP 3 BENZOYL PEROXIDE ACNE MEDICATION ALL SKIN TYPES 1.7 FL.OZ.LIQ./50 ml ℮ Principal Display Panel
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.DO NOT USE IF YOU HAVE VERY SENSITIVE SKIN ARE SENSITIVE TO BENZOYL PEROXIDE
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 MECICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
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 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 SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THIS TIME. IF IRRITATION OCCURS, USE ONLY ONE TOPICAL ACNE MEDICATION AT AT TIME AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING OR POSSIBLY SWELLING. IRRITATION MAY 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.WARNING: FOR EXTERNAL USE ONLY DO NOT USE IF YOU HAVE VERY SENSITIVE SKIN ARE SENSITIVE TO BENZOYL PEROXIDE WHEN USING THIS PRODUCT SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THIS TIME. IF IRRITATION OCCURS, USE ONLY ONE TOPICAL ACNE MEDICATION AT AT TIME AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION STOP USE AND ASK A DOCTOR IF IRRITATION BECOMES SEVERE KEEP OUT OF REACH OF CHILDREN IF SWALLOWED, GET MECICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
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