SIMPLICITY DESENSITIZING- lidocaine gel 
Simplicity Laser, 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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Simplicity Desensitizing Gel

Active Ingredient:

Lidocaine 4% w/w

Purpose


Topical anesthetic

Use:

temporarily relieves pain and itching due to:

Warnings:

For external use only.

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

  • Allergic reaction occurs
  • Condition worsens or does not improve within 7 days
  • Symptoms clear up and return within a few days
  • Redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Other Information

Store at USP controlled room temperature 20-25 deg.C (68-77 deg.F).

Inactive ingredients

Ag,carbomer 940, deionized water

Simplicity Desensitizing Gel, 1 fl oz/30mL (69109-004-30)

Label1

Label2

SIMPLICITY DESENSITIZING 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69109-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69109-004-3030 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/15/2014
Labeler -  Simplicity Laser, LLC (079456595)
Establishment
NameAddressID/FEIBusiness Operations
Results RNA, LLC078395000manufacture(69109-004)

Revised: 7/2014
Document Id: fc59ad0a-e1a6-40e9-a273-07086413c616
Set id: 8660021c-69c4-49c3-959d-2182c581aa0f
Version: 4
Effective Time: 20140715
 
Simplicity Laser, LLC