PAIN RELIEF SLEEVE LARGE- menthol patch PAIN RELIEF SLEEVE EXTRA LARGE- menthol patch PAIN RELIEF SLEEVE MEDIUM- menthol patch

Pain Relief Sleeve by

Drug Labeling and Warnings

Pain Relief Sleeve by is a Otc medication manufactured, distributed, or labeled by Great Lakes Wholesale, Marketing, and Sales, Inc, Illinois Industrial Tool, Inc, Planet (Suzhou) Medical Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 16.0%

PURPOSE

Topical Analgesic Patch

INDICATIONS & USAGE

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

• arthritis
• strains
• bruises
• sprains

WARNINGS

For external use only

When using this product:

• avoid contact with eyes
• do not apply to wounds or damaged skin
• do not bandage tightly
• do not use with heating pad

STOP USE

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.

KEEP OUT OF REACH OF CHILDREN

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

INSTRUCTIONS FOR USE

• Adults and children over 12 years: pull sleeve onto knee or large ankles or elbows until the colored section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight.
• Children 12 years or younger: consult a doctor

INACTIVE INGREDIENT

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.

DESCRIPTION

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

• ELBOT
• ANKLE
• WRIST

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

• ELBOW
• ANKLE
• WRIST

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

DOSAGE & ADMINISTRATION

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF SLEEVE  LARGE
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64092-520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64092-520-01	5 mL in 1 PATCH; Type 0: Not a Combination Product	12/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/05/2016

PAIN RELIEF SLEEVE  EXTRA LARGE
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64092-544
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64092-544-01	5 mL in 1 PATCH; Type 0: Not a Combination Product	12/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/05/2016

PAIN RELIEF SLEEVE  MEDIUM
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64092-506
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64092-506-01	5 mL in 1 PATCH; Type 0: Not a Combination Product	12/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/05/2016

Labeler - Great Lakes Wholesale, Marketing, and Sales, Inc (361925498)

Registrant - Illinois Industrial Tool, Inc (628032898)

Establishment
Name	Address	ID/FEI	Business Operations
Planet (Suzhou) Medical Products Co., Ltd		528194366	manufacture(64092-506, 64092-520, 64092-544)