LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride gel 
Provision Medical

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

Benzalkonium

Chloride 0.13% ...

Lidocaine

HCl 0.5%

Purpose

First aid

antiseptic

Topical

analgesic

Uses

Warnings

For external use only

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor

Keep out of reach of children

If ingested contact a Poison Control Center right away.

Directions

Inactive Ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Principal Display Panel – 0.9 g Packet Label

First Aid Burn Cream

The Provision
First Aid
Line™

For Burns
and Cuts

0.9 g (1/32 oz.)

Principal Display Panel – 0.9 g Packet Label
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-5000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
propylene glycol (UNII: 6DC9Q167V3)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
water (UNII: 059QF0KO0R)  
menthol (UNII: L7T10EIP3A)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-5000-00.9 g in 1 PACKET; Type 0: Not a Combination Product07/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/25/2022
Labeler - Provision Medical (036936831)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(69103-5000)

Revised: 11/2013
Document Id: cccceda1-ec11-4306-8dc8-fce4e3eb3a98
Set id: a4b62642-197f-4d88-a475-72d5acf35bcd
Version: 1
Effective Time: 20131111
 
Provision Medical