ASSURED PAIN RELIEF HOT PATCH  - menthol, capsicum oleoresin 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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Drug Facts

Active ingredients                                                                         Purpose

Menthol 30mg...............................................................................Topical Analgesic

Capsicum Extract (capsaicin) 8.3mg...............................................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

Inactive ingredients

aloe vera, aluminum hydroxide, disodium EDTA, gelatin, kaolin, methacrylic acid copolymer, methylparaben, polysorbate 80, sorbitan monostearate, sorbitol solution, tartaric acid, titanium dioxide, tocopheryl acetate (vitamin E), water

Distributed by:

Greenbrier International, Inc.

500 Volvo Parkway

Chesapeake, VA 23320

Made in Korea

image of carton label

ASSURED PAIN RELIEF HOT PATCH  
menthol, capsicum oleoresin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1889
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN8.3 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITOL (UNII: 506T60A25R)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-1889-21 in 1 BOX
12 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/31/2013
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)

Revised: 3/2013
Document Id: bdfcac69-a9c7-485f-8d70-c765bb8fc1bb
Set id: 13b9440e-2ee3-45c6-ab71-fdabb25ae115
Version: 5
Effective Time: 20130331
 
GREENBRIER INTERNATIONAL, INC.