Otc - Active Ingredient
Trolamine Salicylate 10%
Arthritis Cream
FDA Label NDC 51316-990
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Arthritis Cream (NDC 51316-990). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Indications & Usage
Temporarily relieves minor pain associated with:
Arthritis
Simple backache
muscle strains
sprains
bruises
Warnings
For external use only
Allergy Alert:
If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Otc - When Using
When using the product
use only as directed
do not bandage tightly or use with a heating pad
avoid contact with eyes or mucous membranes
do not apply to wounds or damaged skin
Otc - Stop Use
Stop use and ask doctor if
condition worsens
symptoms persist for more than 7 days or clear up and occur again within few days
redness is present
irritation develops
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control right away. (1-800-222-1222)
Dosage & Administration
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 and younger: ask a doctor
Other Safety Information
Store at 20° - 25°C (68° - 77°F)
Inactive Ingredient
Aloe barbadensis leaf juice, cetyl alcohol, glycerin, mineral oil, phenoxyethanol, stearic acid, triethanolamine, water, xanthan gum
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