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| Product NDC Code | 82517-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Hunter beach 4% |
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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 | LOTION | ||||
| RxCUI drug identifier | 2599519 | ||||
| Application Number | part348 | ||||
| Labeler Name | HUNTERS BEACH LIFE | ||||
| 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 Lidocaine 4%
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 and children 2 years or older: apply to affected area not more than 3-4 times daily • Children under 2 years of age: do not use, ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Carthamus Tinctorius (Safflower) Seed Oil, Glycerin, Cetearyl Alcohol, Polysorbate 60, Microcrystalline Cellulose, Algin, Glyceryl Stearate, Sorbitan Caprylate, Propanediol, Benzoic Acid, Euphorbia Cerifera (Candelilla) Wax, Tocopheryl Acetate, Fragrance, Triethanolamine
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 • Temporary relief of pain and itching • Helps relieve and soothes pain from sunburn, minor burns, skin irritations, scrapes, insect bites
Purpose
Information about the drug product’s indications for use.Purpose Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Hunter Beach 4% Lidocaine LIDOCAINE LIDOCAINE ALOE VERA LEAF SAFFLOWER OIL GLYCERIN CETOSTEARYL ALCOHOL POLYSORBATE 60 MICROCRYSTALLINE CELLULOSE SODIUM ALGINATE GLYCERYL MONOSTEARATE SORBITAN MONOCAPRYLATE PROPANEDIOL BENZOIC ACID CANDELILLA WAX .ALPHA.-TOCOPHEROL ACETATE TROLAMINE
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.Packaging Lotion
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.Drug Facts
NEW! Lidocaine Lotion with Aloe Vera Instant Maximum Relief For Severe Sunburns Distributed by Hunters Beach Life, 1707 State Ave., Holly Hill, FL 32117 www.HUNTERBEACH.com Made in the U.S.A.
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 the reach of children . If swallowed get medical help or contact a Poison Control Center right away
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. Do not use in large quantities, particularly over raw surfaces or areas with blisters. When using this product avoid contact with eyes. Use only as directed. Intentional misuse by deliberate concentrating and inhaling the contents can be harmful or fatal. Stop use and consult a doctor if condition worsens, or symptoms last more than 7 days. Symptoms clear up and occur again within a few days. Keep out of the reach of children . 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