GLACIERIX- capsaicin-menthol patch 
Pharmaco Technology LLC

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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PDP

warnings and precautions

DOSAGE AND ADMINISTRATION

WARNINGS

INACTIVE INGREDIENT

INDICATIONS AND USAGE

OTC - PURPOSE

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - ACTIVE INGREDIENT

GLACIERIX 
capsaicin-menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69691-150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM) capsaicin.0375 g  in 100 g
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
propylparaben (UNII: Z8IX2SC1OH)  
aloe vera leaf (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
methylparaben (UNII: A2I8C7HI9T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
glycerin (UNII: PDC6A3C0OX)  
water (UNII: 059QF0KO0R)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69691-150-15100 g in 1 BOX; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)04/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2015
Labeler - Pharmaco Technology LLC (079722491)

Revised: 3/2015
Document Id: 11f7a728-c7bf-11a2-e054-00144ff88e88
Set id: 11f7a728-c7be-11a2-e054-00144ff88e88
Version: 1
Effective Time: 20150323
 
Pharmaco Technology LLC