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| Product NDC Code | 61010-4403 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain relieving |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 415974 | ||||
| Application Number | M017 | ||||
| Labeler Name | Safetec of America, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol USP 4%
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 : Rub a thin film over affected areas not more than 4 times daily; massage not necessary Children under 2 years of age: Consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leal), Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, TocopheryI Acetate, Triethanolamine.
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.Use Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backache, strains sprains.
Purpose
Information about the drug product’s indications for use.Purpose Cooling Pain Relief
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relieving menthol ALOE VERA LEAF ARCTIUM LAPPA ROOT ARNICA MONTANA FRANKINCENSE FD&C BLUE NO. 1 CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CAMPHOR (NATURAL) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) GLYCERIN ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL MELISSA OFFICINALIS LEAF WATER SILICON DIOXIDE FD&C YELLOW NO. 5 .ALPHA.-TOCOPHEROL ACETATE TRIETHYLAMINE 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 – 4 oz Pain Relieving Gel Safetec ® Pain Relieving Gel For Minor Aches & Pains of Muscles & Joints Net Wt. 4 oz. (113.4g) Reorder No. 58002 Manufactured for: Safetec of America, Inc. Buffalo, NY 14215 I 1-800-456-7077 Made in India KD/739 Principal Display Panel – 4 oz Pain Relieving Gel
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
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 a doctor before use if you have: sensitive skin.
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, contact a physician or Poison Control Center right away
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store in a cool dry place.
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 Symptoms last more than 7 days or 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: Avoid contact with eyes or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Wash hands after use with cool water Do not use with heating pad or device
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding : Ask a health professional before use.
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. Flammable: Keep away from excessive heat or open flame. Ask a doctor before use if you have: sensitive skin. When using this product: Avoid contact with eyes or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Wash hands after use with cool water Do not use with heating pad or device Stop use and ask a doctor if: Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days. If pregnant or breast feeding : Ask a health professional before use.
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