COLD HOT PATCH- menthol patch

cold hot patch by

Drug Labeling and Warnings

cold hot patch by is a Otc medication manufactured, distributed, or labeled by Simple Diagnostics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 5.00%.

Purpose

Topical analgesic

Use

temporarily relieves minor aches and pains of muscles and joints due to
.arthritis .simple backache .strains . sprains
.bursitis .tendonitis . Bruises . Cramps

Warnning

For external use only.
When using this product.use only as directed . avoid contact with eyes and mucous membranes. do not apply to wounds or damaged skin.do not bandage tightly or use a heating pad
Stop use and ask doctor if
.excessive redness or irritation is present
.condition worsens
.pain persist for more than 7 days
.symptoms clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use, keep out of reach of childeren.If swallowed, get medical help or contact a poison control center right away.

keep out of reach of childeren.If swallowed, get medical help or contact a poison control center right away.

Directions

.adults and children 12 years and over: apply patch to affected area as needed but not more than 4 times daily
.children under 12 years: ask a doctor
. for easy application: grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates.
Remove protective film while applying pad directly to site of pain.

Inactive Ingredients

Acrylic Acid,Aluminum Hydroxide,Carmellose Sodium,2 Ethylhexyl Acrylate,Glycerin,Isopropyl Myristate,Methyl Acrylate,Nonoxynol 30,
Polyacrylate,Polyacrylic Acid,Polysorbate 80,Sorbitan Sesquioleate,Starch,Talc,Tartaric Acid,Titanium Dioxide,Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD HOT PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62379-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
NONOXYNOL-30 (UNII: JJX07DG188)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STARCH, POTATO (UNII: 8I089SAH3T)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62379-001-35	4 in 1 CARTON
1		12 in 1 PACKAGE
1		1 in 1 BOX
1		2 in 1 BAG
1	NDC: 62379-001-25	.408 g in 1 PATCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/23/2015

Labeler - Simple Diagnostics, Inc. (004135503)