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Icy Hot Back

Medically reviewed on July 31, 2018

Dosage form: patch
Ingredients: MENTHOL 428.5mg
Labeler: Lead Chemical Co. Ltd.
NDC Code: 62168-1000

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Icy Hot® Patch

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

ICY HOT BACK 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-1000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL428.5 mg
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID 
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
2-ETHYLHEXYL ACRYLATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
NONOXYNOL-30 
SODIUM POLYACRYLATE (2500000 MW) 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
SORBITAN SESQUIOLEATE 
STARCH, CORN 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:62168-1000-15 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2013
Labeler - Lead Chemical Co. Ltd. (693727091)
Registrant - Lead Chemical Co. Ltd. (693727091)
Establishment
NameAddressID/FEIOperations
Lead Chemical Co. Ltd.693727091ANALYSIS(62168-1000), MANUFACTURE(62168-1000)

 
Lead Chemical Co. Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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