Your browser does not support JavaScript! QC COLD AND HOT PAIN RELIEF (MENTHOL) PATCH [CHAIN DRUG MARKETING ASSOCIATION INC]
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QC COLD AND HOT PAIN RELIEF (menthol) patch
[CHAIN DRUG MARKETING ASSOCIATION INC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredient

Menthol 5.0%

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

For external use only

When using this product

  • use only as directed
  • avoid contact with eyes and mucous membranes
  • do not bandage tightly or use with a heating pad
  • do not apply to wounds or damaged skin, broken or irritated skin

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation 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 health professional before use

Keep out of reach of children.

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

Directions

Adults and children over 12 years:

  • carefully remove backing from patch
  • apply one patch to affected area
  • repeat as necessary, but no more than 4 times daily

Children 12 years or younger: ask a doctor

Inactive ingredients

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

package label

QC Cold and Hot Patchimage of carton label

QC COLD AND HOT PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-012
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL400 mg
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID 
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
NONOXYNOL-30 
POLYSORBATE 80 
SORBITAN SESQUIOLEATE 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:63868-012-051 in 1 CARTON
15 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/12/2011
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Revised: 11/2012
Document Id: fd590103-7b29-4783-af34-cd3893643384
Set id: 1ff58c3a-95c1-4ca0-81d8-ce580f08481d
Version: 1
Effective Time: 20121107
 
CHAIN DRUG MARKETING ASSOCIATION INC

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