LEADER ULTRA STRENGTH PAIN RELIEVING- menthol patch

Leader Ultra Strength Pain Relieving by

Drug Labeling and Warnings

Leader Ultra Strength Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                     Purpose

Menthol 5%..........................................................Topical Analgesic

PURPOSE

Uses 

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

• simple backache 
• arthritis
• strains
• bruises
• sprains

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions

ASK DOCTOR

Ask a doctor before use if you have

• redness over the affected area

WHEN USING

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly

STOP USE

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

INDICATIONS & USAGE

Directions

• open pouch and remove patch
• if desired, cut patch to size
• peel off protective backing and apply sticky side to affected area
• adults and children 12 years of age and older:apply to affected area not more than 3 to 4 times daily
• children under 12 years of age:consult a doctor

STORAGE AND HANDLING

Other information

• store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT

Inactive ingredients

butylated hydroxytoluene, carboxymethylcellulose sodium, castor oil, edetate disodium, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminum hydroxide, methylparaben, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

DOSAGE & ADMINISTRATION

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER ULTRA STRENGTH PAIN RELIEVING 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0185
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CASTOR OIL (UNII: D5340Y2I9G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KAOLIN (UNII: 24H4NWX5CO)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0185-1	1 in 1 BOX	11/28/2016
1		5 in 1 POUCH
1		1 in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/28/2016

Labeler - Cardinal Health, Inc. (097537435)