CVS COLD AND HOT- lidocaine, menthol patch

CVS Cold and Hot by

Drug Labeling and Warnings

CVS Cold and Hot by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Adults/children 12 years and older
• clean and dry affected area
• remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
• carefully remove smaller portion of 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 patch to affected area
• use 1 patch for up to 12 hours

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%

• Desensitizes
  aggravated nerves
• Easy to apply
• Fast acting

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 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%

• Desensitizes
  aggravated nerves
• Easy to apply
• Fast acting

Topical Anesthetic

Topical Analgesic

1 PATCH

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

INGREDIENTS AND APPEARANCE

CVS COLD AND HOT 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-218
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-218-05	5 in 1 BOX	12/01/2017
1		1 in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/01/2017

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-218)