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Sunmark arthricream rub - Medication Information

Product NDC Code 49348-883
Drug Name

Sunmark arthricream rub

Type Brand
Active Ingredients
Trolamine salicylate 10 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 313518
Application Number part348
Labeler Name Strategic Sourcing Services LLC
Packages
Package NDC Code Description
49348-883-84 1 tube in 1 carton (49348-883-84) / 85 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Trolamine salicylate 10%

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, but not 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 aloe barbadensis leaf juice, cetyl alcohol, edetate disodium, glycerin, methylparaben, mineral oil, potassium phosphate, propylparaben, stearic acid, 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 temporarily relieves minor pain associated with: • arthritis • simple backache • muscle 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.
sunmark arthricream rub Trolamine Salicylate TROLAMINE SALICYLATE SALICYLIC ACID ALOE VERA LEAF CETYL ALCOHOL EDETATE DISODIUM GLYCERIN METHYLPARABEN MINERAL OIL POTASSIUM PHOSPHATE, UNSPECIFIED FORM PROPYLPARABEN STEARIC ACID TROLAMINE WATER

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 COMPARE TO ASPERCREME® PAIN RELIEVING CREME ACTIVE INGREDIENT Trolamine salicylate, 10% PAIN RELIEVING CREAM arthricream rub WITH ALOE Trolamine salicylate, 10% PAIN RELIEVING CREAM NET WT 3 OZ (85 g) 251-s1-arthricream-rub-1.jpg 251-s1-arthricream-rub-2.jpg

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? 1-800-719-9260

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 or use with a heating pad • avoid contact with the eyes or mucous membranes • do not apply to wounds or damaged skin

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

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 Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product • use only as directed • do not bandage tightly or use with a heating pad • avoid contact with the eyes or mucous membranes • do not apply to wounds or damaged 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 If pregnant or breast-feeding, ask a health professional before use. 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