ASSURED PAIN RELIEF HOT MENTHOL- menthol patch 
Greenbrier International, 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.

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Assured Pain Relief Hot Patches, 2ct 6156, 2019

Active Ingredient                                                                     Purpose

Menthol 30mg--------------------------------------------------------- Topical analgestic

Capsicum extract (capsaicin) 8.3mg--------------------------------- Topical analgestic

Uses  Temporarily relieves minor pain associated with:

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of chidren.

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

Directions

Inactive ingredients

aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, tatanium dioxide, tocopherol acetate

Release liner: polypropylene, non-woven material: polyester non-woven fabric

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

MADE IN KOREA

image description

ASSURED PAIN RELIEF HOT MENTHOL 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-6156
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 100 mg
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN8.3 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CASTOR OIL (UNII: D5340Y2I9G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-6156-32 in 1 CARTON10/17/2014
130 mg in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/17/2014
Labeler - Greenbrier International, Inc (610322518)

Revised: 12/2019
Document Id: 98fac366-b1a3-0775-e053-2a95a90a5d8b
Set id: 4588d98b-c905-4729-9b40-722c344284b9
Version: 3
Effective Time: 20191205
 
Greenbrier International, Inc