ARTHRITIS LEADER- trolamine salicylate cream

Arthritis by

Drug Labeling and Warnings

Arthritis by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Trolamine Salicylate 10.0%

INDICATIONS & USAGE

Uses

Temporarily relieves minor pain associated with:  arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

WARNINGS

Warnings

For external use only. 

Allergy alert: if prone to allergic reaction from aspirin or salicylate, contact 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 eyes or mucous membranes, and do no apply to wounds or damaged skin

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, redness present, or irritation develops

If pregnant or breast-feeding, ask a health care professional before use

DOSAGE & ADMINISTRATION

Directions

Adults and children over 12 years of age:  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

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.

PURPOSE

Purpose

Pain relieving gel.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

PRINCIPAL DISPLAY PANEL

Leader Arthritis Cream with Aloe.

INGREDIENTS AND APPEARANCE

ARTHRITIS  LEADER
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-750
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Trolamine Salicylate (UNII: H8O4040BHD) (Trolamine - UNII:9O3K93S3TK)	Trolamine Salicylate	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Cetyl Alcohol (UNII: 936JST6JCN)
Glycerin (UNII: PDC6A3C0OX)
Methylparaben (UNII: A2I8C7HI9T)
Mineral Oil (UNII: T5L8T28FGP)
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)
Propylparaben (UNII: Z8IX2SC1OH)
Stearic Acid (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-750-21	1 in 1 CARTON
1		85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/01/2012

Labeler - Cardinal Health (097537435)