LEADER EXTRA STRENGTH MEDICATED PAIN RELIEF PATCH- menthol patch 
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient                                         Purpose

Menthol 5%.............................................. Topical analgesic

Uses

Temporarily relieves minor pain associated with:

Warnings

For external use only

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

When using this product

Stop use and ask a doctor if:

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

1,3-butylene glycol, aloe vera (powder), dibutylhydroxytoluene, disdoium edate, d-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminum hydrate, metacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium oxide, tocopherol acetate

DISTRIBUTED BY:

CARDINAL HEALTH

DUBLIN, OHIO 43017 USA

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LEADER EXTRA STRENGTH MEDICATED PAIN RELIEF PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-083
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE VERA FLOWER (UNII: 575DY8C1ER)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
PARAFFIN (UNII: I9O0E3H2ZE)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TARTARIC ACID (UNII: W4888I119H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-083-701 in 1 BOX
11 g in 1 PATCH
2NDC:49781-083-715 in 1 BOX
21 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/25/2014
Labeler - Cardinal Health (097537435)

Revised: 12/2014
Document Id: 2b839fb3-6dd4-42c2-ba99-fdaa1272cd3b
Set id: f7a550a0-1c0d-40df-b7e6-734ac4f999f3
Version: 3
Effective Time: 20141210
 
Cardinal Health