Extra Strength Cold n Hot Pain Relief Medicated

Dosage form: patch
Ingredients: MENTHOL 5g in 100g
Labeler: Greenbrier International , Inc.
NDC Code: 33992-7000

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.

Extra Strength Cold'n Hot Pain Relief Medicated Patch

Active Ingredients

Menthol 5%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:

arthritis

simple backache

bursitis

tendonitis

muscle strains

muscle sprains

bruises

cramps

Warnings

For external use only

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

When using this product

use only as 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 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

Keep out of reach of children.

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

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 patch to site of pain.

Carefully remove remaining film while pressing patch to skin for secure adhesion.

Store unused patch in pouch. Reseal pouch after opening.

Other information

Store at 20 to 25C (68 to 77F)

Inactive Ingredients

Aloe Vera, Aluminum hydroxide, BHT, Caster 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, titanium dioxide, tocopherol acetate (vitamin E).

Release Liner: polypropylene, non-woven aterial: polyester non-woven fabric

Extra Strength

Cold'n Hot

Pain Relief Medicated Patch

Assured COLDnHOT is a soft, flexible, pain relieving patch. It provides fast, long-lasting, soothing pain relief that lasts for hours right where it hurts.

Cold n Hot relieving patch is thin enough to wear unnoticed under clothes day or night. it adheres firmly on muscles or joings yet removes easily. it is not messy or greasy and will not stain your clothing. Only you will know that you are wearing the patch. Store unused patch in the pouch. Reseal pouch after opening.



*This product is not manufactured or distributed by Chattem, Inc. Chattanooga, TN 37409

Distributed by:

Greenbrier International, Inc.

500 Volvo Parkway

Chesapeake, VA 23320

Made in China

Assured

Extra Strength

Cold n Hot

Pain Relief Medicated Patch

NATURAL MENTHOL 5%

Pain relieving menthol gel on a breathable adhesive patch.

Menthol hot therapy for pain

Cold and hot pain relief

Contains vitamin E and Aloe



2 patches

3 1/8" x 4 5/8" (8x12cm) EACH



*Compare to the performance of Icy Hot Patch

EXTRA STRENGTH COLD N HOT PAIN RELIEF MEDICATED 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-7000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALUMINUM HYDROXIDE 
BUTYLATED HYDROXYTOLUENE 
CASTOR OIL 
EDETATE DISODIUM 
GELATIN 
GLYCERIN 
ISOPROPYL MYRISTATE 
KAOLIN 
MAGNESIUM ALUMINOMETASILICATE TYPE I-A 
METHYLPARABEN 
POLYETHYLENE GLYCOL 
POLYSORBATE 80 
POLYVINYL ALCOHOL 
WATER 
TARTARIC ACID 
TITANIUM DIOXIDE 
ALPHA-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:33992-7000-22 PATCH (PATCH) in 1 BOX
10.48 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/03/2011
Labeler - Greenbrier International , Inc. (610322518)

Revised: 03/2011
 
Greenbrier International , Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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