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Herb street backache and sore muscle relief - Medication Information

Product NDC Code 10107-432
Drug Name

Herb street backache and sore muscle relief

Type Brand
Active Ingredients
Menthol .1 g/g
Route TOPICAL
Dosage Form STICK
Application Number M017
Labeler Name Balassa Laboratories Inc.
Packages
Package NDC Code Description
10107-432-02 1 tube in 1 carton (10107-432-02) / 16.8 g in 1 tube (10107-432-01)
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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 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, glyceryl stearate, 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 YELLOW WAX AVOCADO OIL SOYBEAN OIL CASTOR OIL CANNABIS SATIVA SEED OIL GLYCERYL MONOSTEARATE PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF ETHYLHEXYLGLYCERIN MENTHOL MENTHOL

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. Carton Image

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 feeding
If 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