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| Product NDC Code | 11822-7958 | ||||
|---|---|---|---|---|---|
| Drug Name | Rite aid hot and cold extra strength |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 311500 | ||||
| Application Number | part348 | ||||
| Labeler Name | Rite Aid Corporation | ||||
| 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 10% Methyl salicylate 30%
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 and over: apply to affected area not more than 3 to 4 times daily children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients glyceryl stearate, isoceteth-20, poloxamer, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine
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 temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis muscle strains bruises muscle sprains
Purpose
Information about the drug product’s indications for use.Purpose Menthol - Topical analgesic Methyl salicylate - Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Rite Aid Hot and Cold Extra Strength Menthol, Methyl salicylate GLYCERYL MONOSTEARATE ISOCETETH-20 POLOXAMER 407 WATER SODIUM LAURYL SULFATE SORBITAN MONOSTEARATE TROLAMINE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM METHYL SALICYLATE SALICYLIC ACID
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 Carton
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 skin redness or excessive irritation of the skin occurs condition worsens 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 use only as directed do not get into eyes or on mucous membranes do not apply to wounds or irritated or damaged skin do not bandage tightly do not use with a heating pad or apply external heat
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 When using this product use only as directed do not get into eyes or on mucous membranes do not apply to wounds or irritated or damaged skin do not bandage tightly do not use with a heating pad or apply external heat Stop use and ask a doctor if skin redness or excessive irritation of the skin occurs condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days
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