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| Product NDC Code | 53329-984 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Activice |
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| Type | Brand | ||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||
| Dosage Form | GEL | ||||||||||||||
| RxCUI drug identifier | 283257, 2119857 |
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| Application Number | part348 | ||||||||||||||
| Labeler Name | Medline Industries, LP | ||||||||||||||
| 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 8.0%
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 over 12 years: apply directly onto affected area without the need to bandage repeat if necessary, but do not apply more than 4 times daily. Children 12 years or younger: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, SD alcohol 39C, PEG-8 dimethicone, pentylene glycol, peppermint oil, triethanolamine, water (USP).
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 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.ActivICE menthol PENTYLENE GLYCOL WATER PEG-8 DIMETHICONE TROLAMINE MENTHOL MENTHOL PEPPERMINT OIL PEPPERMINT ALCOHOL HYDROXYPROPYL CELLULOSE (1600000 WAMW) EUCALYPTUS OIL GLUCOSAMINE SULFATE DIMETHYL SULFONE
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.Package Label Label V3 RF23MFO PDP2
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.Manufacturing Information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA www.medline.com 1-800-MEDLINE (633-5463) REF: MDSAICEGEL, MDSAICEGELR V3 RF23MFO, V4 RC22MFO
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 helop or contact a 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 at room temperature
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 doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days redness is present excessive irritation of the skin develops
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 do not bandage tightly or use with heating pad do not apply to wounds or damaged skin
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, 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. Avoid contact with eyes. Flammable: keep away from fire or flame. When using this product use only as directed do not bandage tightly or use with heating pad do not apply to wounds or damaged skin Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days redness is present excessive irritation of the skin develops If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical helop 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