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Product NDC Code | 72625-130 | ||||
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Drug Name | Ultra vedic |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
Application Number | part348 | ||||
Labeler Name | Pharmaneek, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 10%
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 For use by Adults and Children 12 year of age and older Apply to the affected area no more than 2 times a day Dry skin completely at application site area, before applying the patch Open pouch and remove patch Peel off protective film and apply sticky side to affected area If applied on hairy skin, remove gently using mild warm water Patch once used cannot be re-pasted or reused Dispose properly after use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Adhesive Plaster, Eucalyptus Oil
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 temporary relief of minor aches and pains in lower back and abdomen associated with cramps.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Ultra Vedic Feminine Pain Relief MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM EUCALYPTUS OIL
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.PRINCIPAL DISPLAY PANEL Please Reseal After Opening NDC: 72625-130-05 ULTRA VEDIC Feminine Pain Relief Patch Pack of 5 Patches Soothe Period Cramps Medicated Patch Fast Acting Apply for 8-12 Hours 7bdf737e-figure-01 7bdf737e-figure-02
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.Feminine Pain Relief Patch The unique combination of pain relievers on the transdermal patch relieve pain due to cramps.
Other Information Store at room temperature below 80°F (27°C)
Distributed by: Pharmaneek, Inc. 7345 Woodland Dr., Ste A, Indianapolis, IN 46278 © 2018. Made in India. NC/DL-378-A&U
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask Your Doctor Before Use if you have redness over the affected area have sensitive skin are pregnant or breast-feeding
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 open wounds, cuts, eyes, and face With a heating pad
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, seek 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 1-866-241-6885 [email protected] www.ultravedic.com
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 Your Doctor If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days If abnormal skin irritation occurs after usage
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 Avoid contact with eyes and mucous membranes Do not bandage tightly
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 otherwise than as directed.
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