Arthricream
FDA Label NDC 21695-310

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Arthricream (NDC 21695-310). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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

Active Ingredient

Trolamine salicylate 10%

Purpose

Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

For external use only

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.

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

Other Information

  • store at 20°-25°C (68°-77°F)

Inactive Ingredients

aloe barbadensis leaf juice, dimethicone, edetate disodium, glyceryl monostearate, methylparaben, PEG-100 stearate, propylene glycol, propylparaben, purified water, sorbitol solution

Questions Or Comments?

1-800-719-9260

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Principal Display Panel

Compare to Aspercreme® active ingredient

Pain Relieving Cream

Arthricream Rub

Trolamine salicylate, 10%

with aloe

Arthricream 10% (E1cfadb7 7370 4735 A87a 071c6eedd87a 01)

Arthricream 10% (E1cfadb7 7370 4735 A87a 071c6eedd87a 01)

* Please review the disclaimer below.