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| Product NDC Code | 53329-156 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Medline |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | PASTE | ||||||||||
| RxCUI drug identifier | 2642278 | ||||||||||
| Application Number | M015 | ||||||||||
| Labeler Name | Medline Industries, LP | ||||||||||
| 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 ingredients Menthol 0.44% w/w White petrolatum 53% w/w Zinc oxide 20.6% w/w
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 adults : when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily Children under 12 years of age : consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients 7-dehydrocholesterol, algae extract (aphanizomenon flos-aquae), beeswax, bisabolol, brassica campestris (rapeseed) sterols, calamine, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) seed oil, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut) oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, manuka honey, olea europaea (olive) oil, phospholipids, phytonadione, simmondsia chinensis (jojoba) seed oil, stearic acid, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zea mays (corn) starch.
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 for the temporary relief of anorectal itching and discomfort in the perianal area associated with anorectal inflammation temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues temporarily protects irritated areas temporarily relieves burning provides temporary relief from skin irritations temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful temporarily protects inflamed perianal skin temporarily relieves the symptoms of perianal skin irritation may provide a cooling sensation
Purpose
Information about the drug product’s indications for use.Purpose Analgesic Protectant Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Medline menthol, white petrolatum, zinc oxide MEDIUM-CHAIN TRIGLYCERIDES HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) PHYTONADIONE YEAST, UNSPECIFIED CORN OIL ALPHA-TOCOPHEROL ACETATE CHOLECALCIFEROL COCONUT OIL GLYCERIN HEXYLDECANOL HONEY OLIVE OIL JOJOBA OIL STEARIC ACID WATER GREEN TEA LEAF CETYLHYDROXYPROLINE PALMITAMIDE ZINC OXIDE ZINC OXIDE APHANIZOMENON FLOSAQUAE YELLOW WAX RAPESEED STEROL FERRIC OXIDE RED MENTHOL MENTHOL STARCH, CORN PETROLATUM PETROLATUM 7-DEHYDROCHOLESTEROL LEVOMENOL SAFFLOWER OIL DIMETHICONE CLOVE
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.Package Label Box_V1 RJ22PUA Packet_V1 RJ22PUA
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Manufacturing information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA of domestic and imported materials 1-800-MEDLINE (633-5463) V1 RJ22PUA REF: MSC092554PACK
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 on deep or puncture wounds animal bites serious burns
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. In case of accidental ingestion, 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 protect from freezing avoid excessive heat not made with Natural rubber Latex
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 condition worsens symptoms last more than 7 days or clear up and occur again within a few days in case of bleeding
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 do not get into eyes do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device applicator
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 Allergy Alert: Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device applicator Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days in case of bleeding Keep out of reach of children. In case of accidental ingestion, get medical 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