HOT AND COLD MEDICATED PATCH- menthol patch

Hot and Cold Medicated Patch by

Drug Labeling and Warnings

Hot and Cold Medicated Patch by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, Beijing HKKY Medical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic

INACTIVE INGREDIENT

Glycerin, Sodium Polyacrylate, Water, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium
Dioxide, Kaolin, Polysorbate 80, Propylene Glycol, Tartaric Acid, PVP, Polyacrylic Acid

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control

INDICATIONS & USAGE

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis
■ muscle strains ■ muscle sprains ■ bruises ■ cramps

WARNINGS

For External Use Only.

DOSAGE & ADMINISTRATION

Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area.

Wear one patch up to 8 hours. Repeat as necessary, but no more than 4 times daily. Reseal pouch after opening.

Children 12 years or younger: Consult a physician.

PURPOSE

Topical Analgesic

When using this product

Use only as directed ■ Don’t bandage tightly or use with heating pad
■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin.

Stop use and ask a doctor

If condition worsens ■ If redness is present ■ If irritation develops
■ If symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breastfeeding

ask a health professional before use.

PRINCIPAL DISPLAY PANEL

DIST. BY
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue
Wayne, PA 19087

INGREDIENTS AND APPEARANCE

HOT AND COLD MEDICATED PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-068
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TARTARIC ACID (UNII: W4888I119H)
POVIDONES (UNII: FZ989GH94E)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-068-05	5 in 1 BOX	10/01/2017
1		1 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	10/01/2017

Labeler - Chain Drug Consortium, LLC (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
Beijing HKKY Medical		544434817	manufacture(68016-068)