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| Product NDC Code | 10578-135 | ||||
|---|---|---|---|---|---|
| Drug Name | Painzaway pain relieving gel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1549850 | ||||
| Application Number | part348 | ||||
| Labeler Name | Indiana Botanic Gardens | ||||
| 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 4.6%
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 ■ See the important warnings under "when using this product" ■ 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 physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Vera Concentrate, Carbomer 940, Emu Oil, FD&C Blue #1, Glucosamine Sulfate, Glycerin, Green Tea Fragrance, Imidazolidinyl Urea, MSM Powder, Propylene Glycol, SD Alcohol 39B, 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 ■ Temporary relief of minor aches and pains of muscles & joints associated with simple backache, arthritis, bruises and sprains. ■ Provides cooling pain relief.
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.Painzaway Pain Relieving Gel Menthol MENTHOL MENTHOL PROPYLENE GLYCOL TROLAMINE ALOE VERA LEAF ALCOHOL TEA LEAF OIL IMIDUREA WATER CARBOMER 940 DIMETHYL SULFONE GLUCOSAMINE SULFATE EMU OIL GLYCERIN FD&C BLUE NO. 1
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.PainzAway® PAIN RELIEVING GEL NET WT. 5 OZ. label
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: Use only if seal is unbroken.
MANUFACTURED BY INDIANA BOTANIC GARDENS, INC. 3401 W. 37TH AVE., HOBART, IN 46342 Website: BotanicChoice.com
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-644-8327
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, or if symptoms persist for 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 ■ Do not heat ■ Do not microwave ■ Do not use near open flame ■ Do not add to hot water or any container when heating water. May cause splattering and result in burns. ■ Avoid contact with 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
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