LEADER CAPSAICIN - capsaicin cream 
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.

----------

Drug Facts

Active ingredient                                                                      Purpose

Capsaicin 0.1%........................................................................Topical analgesic

For the temporary relief of minor pain associated with:

Warnings

For external use only

When using this product

Stop use and ask a doctor if

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

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 18 years:

Children 18 years or younger: Ask a doctor

Inactive ingredients

Benzyl alcohol, cetyl alcohol, citric acid, glyceryl stearate SE, isopropyl myristate, PEG 100 stearate, petrolatum, purified water, sorbitol

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 3696283

www.myleader.com

1-800-200-6313

Made in Korea

image of carton labelEnter section text here

LEADER CAPSAICIN 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-641
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-641-131 in 1 CARTON
142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 3/2012
Document Id: 9e5604b2-fb26-4725-9c93-66ba917eecd6
Set id: a9d79a94-efa4-455a-99e3-56bf4de5d618
Version: 3
Effective Time: 20120301
 
CARDINAL HEALTH