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Product NDC Code | 73287-028 | ||||
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Drug Name | Hemorrhoid pain relief |
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Type | Brand | ||||
Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M015 | ||||
Labeler Name | Telebrands Corp | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Lidocaine 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 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 to affected area. Apply to the affected area up to 6 times a day Children under 12 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water/Aqua/Eau, Ethylhexyl Stearate,Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride,Cannabis Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, CetearylAlcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric)Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 AlkylAcrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin,Hexylene Glycol, Sodium Hydroxide, Disodium EDTA
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 pain, burning, itching and discomfort associated with hemorrhoids.
Purpose
Information about the drug product’s indications for use.Purpose Lidocaine 5%................Local Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Hemorrhoid Pain Relief Lidocaine HEXYLENE GLYCOL TURMERIC ALLANTOIN GLYCERIN SUNFLOWER OIL STEARIC ACID CANNABIS SATIVA SEED OIL PEG-100 STEARATE DIMETHICONE PHENOXYETHANOL ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) ETHYLHEXYLGLYCERIN MEDIUM-CHAIN TRIGLYCERIDES .ALPHA.-TOCOPHEROL ACETATE GLYCERYL MONOSTEARATE CETOSTEARYL ALCOHOL CAPRYLYL GLYCOL SODIUM HYDROXIDE EDETATE DISODIUM ANHYDROUS ETHYLHEXYL STEARATE BUTYLENE GLYCOL WATER LIDOCAINE LIDOCAINE
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.Hempvana NDC 73287-028-01 Maximum OTC Strength Hemorrhoid Pain Relief Topical Anesthetic Cream 5% Lidocaine + Hemp Seed Oil For Moisturization Net Wt. 3oz (85g) 100% Fragrance Free 1 2
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 and pets. 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 (855) 877-4503 (M-F, 9am-5pm EST)
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 if condition worsens or does not improve within 7 days in case of bleeding symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Certain persons can develop allergic reactions to ingredients in this product.
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 exceed the recommended daily dosage unless directed by a doctor. use only as directed. Read and follow all directions and warnings on this label. do not put this product into the rectum by using finger or any mechanical device or applicator.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Do not use if seal is broken or missing
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: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product do not exceed the recommended daily dosage unless directed by a doctor. use only as directed. Read and follow all directions and warnings on this label. do not put this product into the rectum by using finger or any mechanical device or applicator. Stop use and ask a doctor if if condition worsens or does not improve within 7 days in case of bleeding symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Certain persons can develop allergic reactions to ingredients in this product. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children and pets. If swallowed, 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