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| Product NDC Code | 10107-432 | ||||
|---|---|---|---|---|---|
| Drug Name | Herb street backache and sore muscle relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | part348 | ||||
| Labeler Name | Balassa Laboratories Inc. | ||||
| 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 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 Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: do not use; consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients avocado oil, yellow wax, castor oil, soybean oil, Cannabis Sativa seed oil, glycerol, phenoxyethanol, tocopheryl acetate, aloe vera leaf extract, ethylhexylglycerin
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 minor aches and pains associated with: simple backache arthritis bruises strains sprains
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.Herb Street Backache and Sore Muscle Relief Menthol MENTHOL MENTHOL YELLOW WAX AVOCADO OIL SOYBEAN OIL CASTOR OIL CANNABIS SATIVA SEED OIL GLYCERIN PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF ETHYLHEXYLGLYCERIN
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.PRINCIPAL DISPLAY PANEL - 16.8 g Tube in Carton Herb Street with Hemp Seed Oil Moisturizer Backache & Sore Muscle Relief 10% Menthol Topical Analgesic Stick NET WT 0.59 oz (16.8 g) No Mess Stick Money Back Guranteed Manufactured by Balassa Laboratories, Inc. PO Box 291161, Port Orange, FL 32129 Made in the USA from US and Imported Materials All rights reserved. All copyrights and trademarks are owned by Balassa Laboratories, Inc. 10107-432-02 Carton
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
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 wounds or damaged skin 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, get medical help or contact a Poison Control Center right away.
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 redness or severe skin irritation occurs symptoms persist for more than 7 days symptoms clear up and occur again within a few days
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 use only as directed avoid contact with eyes and mucous membranes do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a healthcare professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at room temperature
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 on wounds or damaged skin with a heating pad When using this product use only as directed avoid contact with eyes and mucous membranes do not bandage tightly Stop use and ask a doctor if condition worsens redness or severe skin irritation occurs symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding ask a healthcare professional before use. Keep out of 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