CVS PAIN RELIEF- lidocaine 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 ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

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

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 86° Fahrenheit, 30° Celsius.

Inactive ingredients

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

Principal Display Panel - Carton Label

CVS Health™

Compare to the active ingredient in Aspercreme® Lidocaine Patch*

MAXIMUM STRENGTH

NDC 66902-203-05

Pain Relief
Patch

UP TO 12 HOURS

ODOR FREE

LIDOCAINE 4%

Topical Anesthetic

Package Contains 5 Individually Wrapped Patches

5 PATCHES

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

Figure

Principal Display Panel - Pouch Label

CVS Health™

Compare to the active ingredient in Aspercreme® Lidocaine Patch*

MAXIMUM STRENGTH

NDC 66902-203-05

Pain Relief
Patch

UP TO 12 HOURS

ODOR FREE

LIDOCAINE 4%

Topical Anesthetic

1 PATCH

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

Figure
CVS PAIN RELIEF 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-203
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
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:66902-203-055 in 1 BOX12/01/2017
11 in 1 POUCH
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(66902-203)

Revised: 12/2017
Document Id: 56755eb0-0ac8-4122-af1a-f58ebae747f4
Set id: e28fa0b1-5654-4871-b748-4a6044869c8f
Version: 1
Effective Time: 20171201
 
NATURAL ESSENTIALS, INC.