QC COLD AND HOT PAIN RELIEF- menthol patch 
CHAIN DRUG MARKETING ASSOCIATION INC

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.

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Drug Facts

Active Ingredient

Menthol 5.0%

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with

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:

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 Type HUMAN OTC DRUG Item Code (Source) NDC:63868-012
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 400 mg
Inactive Ingredients
Ingredient Name Strength
ACRYLIC ACID (UNII: J94PBK7X8S)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
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:63868-012-05 1 in 1 CARTON
1 5 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/12/2011
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