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| Product NDC Code | 59898-805 | ||||||||||||||||||||||
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| Drug Name | Muscle |
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| Type | Brand | ||||||||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||||||||
| Dosage Form | GEL | ||||||||||||||||||||||
| RxCUI drug identifier | 808955 | ||||||||||||||||||||||
| Application Number | part348 | ||||||||||||||||||||||
| Labeler Name | WATER-JEL TECHNOLOGIES | ||||||||||||||||||||||
| 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 3.5%
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 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis leaf juice, angelica archangelica root extract, camphor, carbomer, DMDM hydantoin, isopropyl alcohol, methylparaben, panax ginseng root extract, triethanolamine, water
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 aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains
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.MUSCLE Menthol ISOPROPYL ALCOHOL ANGELICA ARCHANGELICA ROOT ASIAN GINSENG ALOE VERA LEAF CARBOMER HOMOPOLYMER TYPE C TROLAMINE DMDM HYDANTOIN METHYLPARABEN CAMPHOR (NATURAL) WATER 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 MJ16
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.Other information store at room temperature apply product directly onto sore areas of the body massage well for best results following application, wash hands well and rinse with cool water
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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-275-343 [email protected] www.waterjel.com Manufactured by Water-Jel Technologies Inc. 50 Broad Street, Carlstadtn NJ 07072 USA
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 conditions worsens symptoms persist for more than 7 days condition clears up and occurs 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 avoid contact with the eyes do not apply to wounds or damaged skin 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 When using this product avoid contact with the eyes do not apply to wounds or damaged skin do not bandage tightly Stop use and ask a doctor if conditions worsens symptoms persist for more than 7 days condition clears up and occurs 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