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First Aid by Provision Medical

Medically reviewed on Dec 4, 2017

Dosage form: cream
Ingredients: benzalkonium chloride 1.3mg in 1g, lidocaine 5.0mg in 1g
Labeler: Provision Medical
NDC Code: 69103-3553

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.

Active ingredient (in each gram)

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses
  • temporary relief of pain associated with minor burns, cuts and scrapes
  • helps protect against harmful bacteria

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
  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage.

Inactive Ingredients

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

Manufactured for:
Provision Medical Products
Palm Desert, CA 92211

Principal Display Panel - Pouch Label

TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

cream Relieves Pain and Helps Prevent Infection

First Aid and Burn 0.9g

The Provision
First Aid
Line™

FIRST AID 
benzalkonium chloride and lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3553
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (benzalkonium) benzalkonium chloride1.3 mg  in 1 g
lidocaine (lidocaine) lidocaine5.0 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
alcohol 
methylparaben 
mineral oil 
paraffin 
propylparaben 
water 
petrolatum 
white wax 
Packaging
#Item CodePackage Description
1NDC:69103-3553-10.9 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/02/2014
Labeler - Provision Medical (036936831)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(69103-3553)

 
Provision Medical

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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