ASSURED EXTRA STRENGTH COLD N HOT  - 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.

----------

Drug Facts

Active ingredient                                                           Purpose

Menthol 5%.....................................................Topical Analgesic

Uses Temporarily relieves minor pain associated with:

Warnings

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 monooleate, 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 EXTRA STRENGTH COLD N HOT  
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-8463
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL750 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
KAOLIN (UNII: 24H4NWX5CO)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITOL (UNII: 506T60A25R)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-8463-21 in 1 CARTON
12 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/2013
Labeler - Greenbrier International, Inc. (610322518)

Revised: 6/2013
Document Id: dbce6c7d-a94c-48b4-9eb3-776c98f5b7e0
Set id: 4b2a58d4-e298-45f3-9c09-ca8dccf57e04
Version: 3
Effective Time: 20130630
 
Greenbrier International, Inc.