PAIN RELIEF LIQUID- menthol liquid 
Great Lakes Wholesale, Marking, and Sales, 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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Menthol 16%

Topical analgesic

temporariy relieves minor pain associated with:

For external use only

When using this product

Flammable

stop use and ask a doctor if

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

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

Adults and children over 12 years;

children 12 years or younger: ask a doctor

acrylates/C10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol 40 (3

0%), water (245-256)

Personal Care Solutions

Maximum Strength

Pain Relief Liquid

with no mess roll-on applicator

Long lasting pain relief

2.5 fl. oz. (73 ml)

Adults and children over 12 years

Liquid Roll on pain relief

PAIN RELIEF LIQUID 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.16 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CAPSAICIN (UNII: S07O44R1ZM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64092-402-0273 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/05/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/05/2016
Labeler - Great Lakes Wholesale, Marking, and Sales, Inc. (361925498)
Registrant - Illinois Industrial Tool, Inc (628032898)
Establishment
NameAddressID/FEIBusiness Operations
Jiangsu Dedi Medical Device Co., Ltd.421353662manufacture(64092-402)

Revised: 12/2016
Document Id: 42eef404-1d3b-5991-e054-00144ff8d46c
Set id: 42eef404-1d3a-5991-e054-00144ff8d46c
Version: 1
Effective Time: 20161205
 
Great Lakes Wholesale, Marking, and Sales, Inc.