PAIN RELIEF SLEEVE LARGE- menthol patch 
PAIN RELIEF SLEEVE EXTRA LARGE- menthol patch 
PAIN RELIEF SLEEVE MEDIUM- menthol patch 
Great Lakes Wholesale, Marketing, 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.

----------

Menthol 16.0%

Topical Analgesic Patch

For temporary relief of minor aches and pains of muscles and joints associated with:

For external use only

When using this product:

Stop using and ask a doctor

if redness is present or irritation develops. Condition worsens, or if symptioms persist for more than 7 days or clear up and occur again within a few days.

If swallowed, get medical help or contact a Poison Control Center immediately

diethylene glycol monoethyl ether acetate, cetanol, glycerol, glycerol monostearate, methylparaben, 2(2-aminoethoxy) ethanol, sorbitan sesquiolate, sodium polyacrylate, polysorbate 80, aloe barbadensis leaf extract, methyl orange-xylene cyanol solution, ethylenediaminetetracetic acid tetrasodium salt hydrate.

NDC 64092-506-1, ITEM 863906

GLS

Personal Care Solutions

Extra Strength

Menthol 16%

Pain Relief Sleeve

KNEE & Small-Medium ankles & elbows

Medicated Sleeve

Pain relieving Lotion on a Breathable Sleeve

Medium

Ideal for KNEE

EXPANDS TO FIT 5" TO 12" (12.5cm to 30.5cm)

IN CIRCUMFERENCE

Contains 1 Sleeve Patch

KNEE

NDC 64092-520-1, ITEM 863920

GLS

Personal Care Solutions

Extra Strength

Menthol 16%

Pain Relief Sleeve

KNEE & Large Ankles & Elbows

Medicated Sleeve

Pain relieving Lotion on a Breathable Sleeve

Large Sleeve

Ideal for KNEE

EXPANDS TO FIT 8" TO 24" (20 CM TO 61 CM)

IN CIRCUMFERENCE

Contains 1 Sleeve Patch

KNEE

NDC 64092-520-1, ITEM 863920

GLS

Personal Care Solutions

Extra Strength

Menthol 16%

Pain Relief Sleeve

KNEE & Large Ankles & Elbows

Medicated Sleeve

Pain relieving Lotion on a Breathable Sleeve

XLarge Sleeve

Ideal for KNEE

EXPANDS TO FIT 12" TO 28" (30.5 CM to 70 CM)

IN CIRCUMFERENCE

Contains 1 Sleeve Patch

KNEE

ELBOW
ANKLE
WRIST

Adults and children over 12 years: pull sleeve onto knee or large ankle or elbow until the colored section of the sleeve is positioned directly over the affected area. sleeve should feel snug, but not tight.

Med Pain Patch Large pain patchX large pain patch

PAIN RELIEF SLEEVE  LARGE
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-520
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYL ORANGE (UNII: 6B4TC34456)  
EDETIC ACID (UNII: 9G34HU7RV0)  
SOLASULFONE (UNII: H12JE4313S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64092-520-015 mL in 1 PATCH; 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
PAIN RELIEF SLEEVE  EXTRA LARGE
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-544
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYL ORANGE (UNII: 6B4TC34456)  
EDETIC ACID (UNII: 9G34HU7RV0)  
SOLASULFONE (UNII: H12JE4313S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64092-544-015 mL in 1 PATCH; 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
PAIN RELIEF SLEEVE  MEDIUM
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-506
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYL ORANGE (UNII: 6B4TC34456)  
EDETIC ACID (UNII: 9G34HU7RV0)  
SOLASULFONE (UNII: H12JE4313S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64092-506-015 mL in 1 PATCH; 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, Marketing, and Sales, Inc (361925498)
Registrant - Illinois Industrial Tool, Inc (628032898)
Establishment
NameAddressID/FEIBusiness Operations
Planet (Suzhou) Medical Products Co., Ltd528194366manufacture(64092-506, 64092-520, 64092-544)

Revised: 12/2016
Document Id: 42f0f24c-97e1-4a3d-e054-00144ff8d46c
Set id: 42f0f24c-97e0-4a3d-e054-00144ff8d46c
Version: 1
Effective Time: 20161205
 
Great Lakes Wholesale, Marketing, and Sales, Inc