PAIN RELIEF 4% LIDOCAINE DRY PATCH- lidocaine patch 
SAFREL PHARMACEUTICALS, LLC

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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Pain Relief 4% Lidocaine Dry Patch

Active ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Warning

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 label.
  • do not allow contact with the eyes
  • 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 or 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 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 health professional before use.

Keep Out of Reach of Children and Pets
  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

  • 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

Inactive Ingredients

aluminum silicate, butylated hydroxytoluene, silicon dioxide, mineral oil, rosin, polyisobutylene (1000 mw), styrene/isoprene/styrene block copolymer, titanium dioxide, .alpha.-tocopherol acetate

Package / Principle Label

Safrel_LIDOCAINE PATCH CARTON_final.jpg

Package / Inner Pouch

Safrel_LIDOCAINE PATCH POUCH_final.jpg

PAIN RELIEF 4% LIDOCAINE DRY PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-911
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MINERAL OIL (UNII: T5L8T28FGP)  
ROSIN (UNII: 88S87KL877)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
ColorwhiteScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71309-911-1515 in 1 BOX03/15/2022
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34803/15/2022
Labeler - SAFREL PHARMACEUTICALS, LLC (080566287)
Registrant - SAFREL PHARMACEUTICALS, LLC (080566287)
Establishment
NameAddressID/FEIBusiness Operations
DR. SABHARWAL'S WOUND CARE862184668manufacture(71309-911)

Revised: 3/2022
Document Id: 559fb16a-fec5-4577-a059-26368f8adfc1
Set id: f0ded8a8-1b8d-4276-964e-3a4d389f8bb5
Version: 1
Effective Time: 20220315
 
SAFREL PHARMACEUTICALS, LLC