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Signature care cool heat - Medication Information

Product NDC Code 21130-339
Drug Name

Signature care cool heat

Type Brand
Active Ingredients
Menthol, unspecified form 10 g/100g
Methyl salicylate 30 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 311500
Application Number part348
Labeler Name Safeway
Packages
Package NDC Code Description
21130-339-21 1 tube in 1 carton (21130-339-21) / 85 g in 1 tube
21130-339-85 1 tube in 1 carton (21130-339-85) / 35 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients 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 over 12 years • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, not more than 3 to 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 carbomer homopolymer, cetyl esters wax, emulsifying wax, oleth-3 phosphate, purified water, stearic acid, 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 pain associated with • arthritis • simple backache • strains • sprains • 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.
Signature Care Cool Heat Menthol, Methyl salicylate MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM METHYL SALICYLATE SALICYLIC ACID CETYL ESTERS WAX OLETH-3 PHOSPHATE WATER STEARIC ACID TROLAMINE

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 Extra Strength Cool Heat Cream COLD & HOT Therapy For Pain COMPARE TO Icy Hot ® Cream active ingredients Temporary relief of: Arthritis, back aches, body aches & sore muscles Extra Strength Cool Heat Cream MENTHOL 10%, METHYL SALICYLATE 30% Pain Relieving Cream COLD & HOT Therapy For Pain COMPARE TO Icy Hot ® Cream active ingredients Temporary relief of: Arthritis, back aches, body aches & sore muscles NET WT 3 OZ (85 g) Signature Care Cool Heat Cream image 1 Signature Care Cool Heat Cream image 2

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. (1-800-222-1222)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? 1-888-723-3929

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 persist for more than 7 days or clear up and occur again within a few days • redness is present • 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 • use only as directed • do not bandage tightly • do not use with a heating pad • avoid contact with the eyes or mucous membranes • do not apply to wounds or damaged or irritated skin

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20°-25°C (68°-77°F)

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 bandage tightly • do not use with a heating pad • avoid contact with the eyes or mucous membranes • do not apply to wounds or damaged or irritated skin Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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