CVS COLD AND HOT- lidocaine, menthol patch 
NATURAL ESSENTIALS, 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 ingredients

Lidocaine 4%

Menthol 1%

Purpose

Topical Anesthetic

Topical Analgesic

Use

For the temporary relief of pain.

Warnings

For external use only

Do not use

  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all directions and warnings on this carton.
  • Rare cases of serious burns have been reported with products of this type
  • Do not apply to wounds or damaged, broken or irritated skin
  • Do not allow contact with the eyes and mucous membranes
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not use at the same time as other topical analgesics
  • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch

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
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast feeding ask a physician before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Children 12 years or younger: ask a doctor

Other information

Store at room temperature – do not exceed 86º Fahrenheit, 30º Celsius.

Inactive ingredients

Benzyl Alcohol, Carboxymethylcellulose Sodium, Dihydroxyaluminium Aminoacetate, Ethanol, Glycerin, Kaolin, Partially Neutralized Polyacrylate, Propylene Glycol, Polysorbate 80, Polyvinyl Pyrrolidone 90, Tartaric Acid , Tetrasodium Edetate, Titanium Dioxide, Urea, Water.

Principal Display Panel - Cold and Hot Patch Box Label

NDC 66902-218-05

MAXIMUM STRENGTH
LIDOCAINE

Cold & Hot
Patch

UP TO
12
HOURS

MEDICATED PAIN RELIEF
WITH MENTHOL

LIDOCAINE 4%

MENTHOL 1%

Topical Anesthetic

Topical Analgesic

Package Contains 5 individually
wrapped Patches

5 PATCHES

3 5/16" x 5 1/2" (10 cm x 14 cm)

Principal Display Panel - Cold and Hot Patch Box Label

Principal Display Panel - Cold and Hot Patch Label

CVS
Health™

Compare to the active ingredients
in IcyHot® Lidocaine Patch
Plus Menthol*

NDC 66902-218-05

MAXIMUM STRENGTH
LIDOCAINE

Cold & Hot
Patch

MEDICATED PAIN RELIEF
WITH MENTHOL

LIDOCAINE 4%

MENTHOL 1%

Topical Anesthetic

Topical Analgesic

1 PATCH

3 5/16" x 5 1/2" (10 cm x 14 cm)

Principal Display Panel - Cold and Hot Patch Label
CVS COLD AND HOT 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-218
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
TARTARIC ACID (UNII: W4888I119H)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-218-055 in 1 BOX12/01/2017
11 in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2017
Labeler - NATURAL ESSENTIALS, INC. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-218)

Revised: 5/2018
Document Id: 3f92b557-c58b-44db-9354-b95000292f4d
Set id: ebcc09c2-b3f9-4c6d-b523-e27a077b5cb2
Version: 1
Effective Time: 20180511
 
NATURAL ESSENTIALS, INC.