ASSURED COLD N HOT PAIN RELIEF MENTHOL- menthol patch

Assured Cold N Hot Pain Relief Menthol by

Drug Labeling and Warnings

Assured Cold N Hot Pain Relief Menthol by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                                     Purpose

Menthol 5%--------------------------------------------------------- Topical analgestic

PURPOSE

Uses

Temporarily relieves minor pains associated with:

• arthritis
• simple backache
• bursitis
• tendonitis
• muscle strains
• muscle cramps

WARNINGS

For external use only

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

WHEN USING

When using this product

• use as only 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 skin

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms persist more than 7 days or clear up and occur again within a few days
• redness is present
• skin irritation develops
• do not apply to wounds or damanged skin

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of chidren.

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

INDICATIONS & USAGE

Directions

• Adults and children 12 years of age and older: apply to affected area no more than 3 to 4 times daily.
• Children under 12 years of age: do not use, consult a doctor.
• For easy application: partially peel back protective film and apply exposed film and apply exposed patch to site of pain.
• Carefully remove remaining film while pressing patch to skin for secure adhesion.

INACTIVE INGREDIENT

Inactive ingredients

aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, tatanium dioxide, tocopherol acetate

Release liner: polypropylene, non-woven material: polyester non-woven fabric

DOSAGE & ADMINISTRATION

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED COLD N HOT PAIN RELIEF MENTHOL 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-6159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CASTOR OIL (UNII: D5340Y2I9G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL (UNII: 532B59J990)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-6159-5	2 in 1 PACKET	10/17/2014
1		5 mg in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/17/2014

Labeler - Greenbrier International, Inc (610322518)