LEADER ULTRA STRENGTH MUSCLE RUB- camphor, menthol, and methyl salicylate cream 
Cardinal Health, Inc.

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.

----------

Active ingredients                                 Purpose

Camphor 4%...................................Topical analgesic

Menthol 10%...................................Topical analgesic

Methyl salicylate 30%.......................Topical analgesic

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

Warnings

For external use only

Do not use

Ask a doctor before use if you

When using this product

Stop use and ask a doctor if

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

glycerin, isopropyl myristate, lanolin, methylparaben, petrolatum, polysorbate 60, potassium cetyl phosphate, propylparaben, sorbitan monostearate, stearyl alcohol, water

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to care™since 1979

Made in Korea

image description

LEADER ULTRA STRENGTH MUSCLE RUB 
camphor, menthol, and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0238
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0238-11 in 1 BOX08/16/2017
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/16/2017
Labeler - Cardinal Health, Inc. (097537435)

Revised: 8/2017
Document Id: 8c45e3c3-e610-4b56-9d81-e5e8758477fd
Set id: 439e9c9c-ccb8-4e33-bee3-6a441e99f629
Version: 1
Effective Time: 20170816
 
Cardinal Health, Inc.