PAIN RELIEF LIQUID- menthol liquid

Pain Relief Liquid by

Drug Labeling and Warnings

Pain Relief Liquid by is a Otc medication manufactured, distributed, or labeled by Great Lakes Wholesale, Marking, and Sales, Inc., Illinois Industrial Tool, Inc, Jiangsu Dedi Medical Device Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 16%

PURPOSE

Topical analgesic

INDICATIONS & USAGE

temporariy relieves minor pain associated with:

• arthritis
• simple backache
• muscle strains
• sprains
• bruises
• cramps

WARNINGS

For external use only

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged, broken or irritated skin
• a transient burning sensation may occur upon application but generally disappears in several days
• if severe burning sensation occurs, discontinue use immediately
• do not expose the area treated with product to heat or direct sunlight

Flammable

• keep away from fire or flame

STOP USE

stop use and ask a doctor if

• condition worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again witin a few days sy

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

INSTRUCTIONS FOR USE

Adults and children over 12 years;

• apply generously to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary, but no more than 3-4 times daily
• IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor

INACTIVE INGREDIENT

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

0%), water (245-256)

DESCRIPTION

Personal Care Solutions

Maximum Strength

Pain Relief Liquid

with no mess roll-on applicator

Long lasting pain relief

• Powerful, fast acting formula
• Deep Penetrating Quick Drying
• Roller Ball Keeps Hands Clean

2.5 fl. oz. (73 ml)

DOSAGE & ADMINISTRATION

Adults and children over 12 years

• apply generously to affected area
• massage into painful area until thoroughly absorbed int skin
• repeat as necessary, but no more than 3-4 times daily.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF LIQUID 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64092-402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.16 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CAPSAICIN (UNII: S07O44R1ZM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64092-402-02	73 mL in 1 BOTTLE, WITH APPLICATOR; 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, Marking, and Sales, Inc. (361925498)

Registrant - Illinois Industrial Tool, Inc (628032898)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Dedi Medical Device Co., Ltd.		421353662	manufacture(64092-402)