ICY HOT BACK- menthol patch

Icy Hot Back by

Drug Labeling and Warnings

Icy Hot Back by is a Otc medication manufactured, distributed, or labeled by Lead Chemical Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

Icy Hot Patch for temporary relief of minor pain associated with bursitis (inflammation of one or more bursae (small sacs) of synovial fluid in the body), tendonitis (inflammation of a tendon), muscle strains, muscle sprains, bruises, cramps, arthritis and simple backache.

Warnings

For external use only

When using this product

• Use only as directed.

Stop use and ask a doctor if

• Condition worsens.
• Irritation or redness develops.
• Symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children.

Directions

• Remove backing from the patch by grasping both ends firmly and gently pulling. Backing separates in the middle.
• Carefully remove smaller portion of the backing from patch and apply exposed portion of patch to affected area.
• Once exposed portion of patch is positioned, carefully remove remaining backing to completely apply remaining part to the affected area.
• Apply one patch to affected area.

Children 12 years or younger, Consult a healthcare practitioner before using.

Precautions

• Wear one Icy Hot Patch up to 8 hours.
• Repeat as necessary, not more than 3 times daily.
• Keep pouch tightly sealed.
• Store at or below 25 °C in a cool, dry place.

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

Other Information

SANOFI

Winthrop Pharmaceuticals (Pty) Ltd, 2 Bond Street, Midrand, 1685, South Africa

Winthrop Pharmaceuticals (Pty) Ltd, 315 Waltloo Road, Pretoria, South Africa

Toll Free No. 0800 601 228 Fax: 011 256 3917

0060434-01

Principal Display Panel

ICY HOT® PATCH

Icy & Hot Therapy for Minor Pain

Icy to Dull the Pain

Hot to Relax it Away

A breathable soft adhesive pad containing a soothing ointment that will relieve soreness and discomfort

Use on your back, arms, legs or shoulders

Lasts up to 8 hours

5 Patches

Contains 5 patches in 1 resealable pouch

10 cm x 20 cm each

Reseal Pouch After Opening

Pouch Label - Back

INGREDIENTS AND APPEARANCE

ICY HOT BACK 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	428.5 mg

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
NONOXYNOL-30 (UNII: JJX07DG188)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-1000-1	5 in 1 POUCH; Type 0: Not a Combination Product	07/01/2013	05/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2013	05/31/2020

Labeler - Lead Chemical Co. Ltd. (693727091)

Registrant - Lead Chemical Co. Ltd. (693727091)

Establishment
Name	Address	ID/FEI	Business Operations
Lead Chemical Co. Ltd.		693727091	ANALYSIS(62168-1000) , MANUFACTURE(62168-1000)