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Product NDC Code | 79974-205 | ||||
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Drug Name | Veneno de abeja aceite de vibora brand |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | OINTMENT | ||||
RxCUI drug identifier | 1101920, 1117110 |
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Application Number | M017 | ||||
Labeler Name | Miramar Cosmetics, Inc DBA Miramar Lab | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Methyl salicylate 10.5%
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 and children 12 years of age or older: apply generously to affected area not more than 3 to 4 times daily. • children under 12 years of age ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Camphor, D&C yellow No.10, DMDM hydantoin, menthol, liquid paraffin, white petrolatum.
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 minor pains associated with muscles and joints, backache, arthritis, strains, sprains, and cramps.
Purpose
Information about the drug product’s indications for use.Purpose External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Veneno de Abeja Aceite De Vibora Brand Methyl Salicylate METHYL SALICYLATE SALICYLIC ACID CAMPHOR (NATURAL) D&C YELLOW NO. 10 DMDM HYDANTOIN MENTHOL, UNSPECIFIED FORM PARAFFIN PETROLATUM
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 Analgesic-205
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
TAMPER EVIDENT: Do not use if printed seal on jar is broken or missing Distributed by essentia lp roducts Miami, FL, 33126 Made In U.S.A. PARABEN FREE
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 to avoid accidental poisoning. 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 305 2618762 M-F 9AM to 4PM Eastern time.
Storage and handling
Information about safe storage and handling of the drug product.Other Information • Store at 15° to 25° C (59° to 77° F)
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 • use only as directed Do not use • on wounds or damaged skin • with a heating pad • on children under 12 years of age • on irritated skin • with a bandage • on eyes, or mucous membranes Ask a doctor before use if redness is present on the affected area. Stop use and ask a doctor if • excessive irritation develops, condition worsens or symptoms persists for more than 7 days • symptoms clear up and occur again within a few days If pregnant or breast-feeding , ask a heath professional before use. Keep out of reach of children to avoid accidental poisoning. 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