LIDOCAINE PATCH- lidocaine 4% patch 
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS

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.

----------

Lidocaine Patch 24 Hours

Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Purpose

Temporarily relieves minor pain.

Dosage and Administration

Directions Adults and children over 12 years:

■ clean and dry affected area

■ carefully remove backing from patch starting at corner

■ apply sticky side of patch to affected area

■ use one patch for up to 24 hours. Discard patch after single use. Children under 12 years of age: consult a physician.

Warnings

For external use only.

Idications and Usage

Uses: Temporaily relieves minor pains.

When using this product

■ use only as directed

■ read and follow all directions and warnings on this carton

■ do not allow contact with the eyes

■ do not use at the same time as other topical analgesics

■ do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ do not microwave

■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor

■ 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 breastfeeding, ask a health professional before use.

Do not Use

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away 800-222-1222

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

Styrene Isoprene Styrene block Copolymer, Alicyclic Saturated Hydrocarbon Resin, White Mineral Oil

Questions

Questions? 1-866-760-6565, Monday - Friday 8:30 a.m - 4:30 p.m. EST

Manufactured for:
AUM Pharmaceuticals
Hauppauge, NY 11788


Made in USA

Pouch

carton

LIDOCAINE PATCH 
lidocaine 4% patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73317-6866
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) (UNII: 1SSZ6HXE7P)  
HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
Color    Score    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73317-6866-515 in 1 CARTON04/21/2021
19 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/21/2021
Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)

Revised: 4/2021
Document Id: dd0f8296-8723-43f0-bca4-c193fc8ac6a9
Set id: 0a31ba9a-8283-4bf8-b6c6-6e331465622f
Version: 1
Effective Time: 20210423
 
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS