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Rexall ice cold analgesic - Medication Information

Product NDC Code 55910-088
Drug Name

Rexall ice cold analgesic

Type Brand
Active Ingredients
Menthol 2 g/100g
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 311502
Application Number part348
Labeler Name Dolgencorp, LLC
Packages
Package NDC Code Description
55910-088-08 227 g in 1 jar (55910-088-08)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Menthol 2%

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 ■ clean affected area before applying product ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients ammonium hydroxide, carbomer, cupric sulphate, FD&C blue no. 1, isopropyl alcohol, magnesium sulphate, sodium hydroxide, thymol, 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 monor aches and pains in muscles and joints associated with: ■ simple backache ■ sprains ■ arthritis ■ strains ■ sports injuries ■ bruises

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.
Rexall ICE COLD ANALGESIC Menthol CARBOXYPOLYMETHYLENE CUPRIC SULFATE MAGNESIUM SULFATE, UNSPECIFIED THYMOL FD&C BLUE NO. 1 ISOPROPYL ALCOHOL SODIUM HYDROXIDE 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.
Package Label Package Label

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use ■ with other topical pain relievers ■ with heating pads or heating devices

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 Keep out of reach of children and pets. 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 ■ condition worsens ■ symptoms last for more than 7 days or clear up and occur again within a few days ■ redness or irritation 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 ■ do not use in or near eyes ■ do not apply to wounds or damaged skin ■ do not bandage tightly

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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

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