The following Structured Product Label (SPL) was submitted to the FDA by Ji Well Health Company for the product Arthritis Plus Gel (NDC 50810-2000). 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 inactive ingredient, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Inactive Ingredients
Aloe vera gel, amica montana (flower extract), cetaryl alcohol, clove oil,
diazolidimyl urea, FD C Blue #1, frangrance, ginger oil, lavender oil,
methylsulfonylmethane (MSM), Methyl paraben, orange oil.
peppermint oil, polysorbate 60, propylene glycol, propylparaben,
purified water, rosemary oil, thyme oil, Vitamin C,
Vitamin E, xanthan gum
Active Ingredients
Camphor 3%
Methol 12%
Methyl Salicylate 15%
Purpose
Topical Analgesic
Counterirritant
Counterirritant
Uses
For temporary relief of minor aches and pains of muscles and joints associated with:
-Simple Backache
-Arthritis
-Sprains
-Strains
-Bruises
Warnings:
For external use only. Avoid contact with
eyes and mucous membranes
-If condition worsens or if symptoms persist for more than 7 days
or clear up and appear again within a few days, discontinue use of this
product and consult a doctor.
-When used for arthritis, if pain persists for more than 10 days or redness
is present or in conditions affecting children under 12 years of age, consult
a physician immediately.
If pregnant or breast feeding, ask a health care professional before use.
Keep out of reach of children: If swallowed, get immediate
medical help or contact poison control center right away
Directions:
Adults and children 12 years of age and older:
apply to the affected area, massage for 1 minute,
use not more than 3-4 times daily, wash hands.
Children under 12 years of age: Consult a physician
Copy Of Label (Ji Label)
* Please review the disclaimer below.
