ANTISEPTIC- benzalkonium chloride, lidocaine hydrochloride cream 
Total Resources International

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 ingredients

Benzalkonium

Chloride 0.13% w/w

Lidocaine

HCI 0.5% w/w

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 – Pouch Label

BE SMART

GET PREPARED

BURN
CREAM
W/ ALOE VERA • FOR MINOR BURNS

0.03 oz [0.90 g]

SINGLE USE

Made in USA • Mfd. for: TOTAL RESOURCES INTL.
Walnut, California 91789

00-BUR-0009 Rev.01 • NDC #55550-902-21

Figure
ANTISEPTIC 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55550-902
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1.3 mg  in 1 g
lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) lidocaine hydrochloride anhydrous5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
alcohol (UNII: 3K9958V90M)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
petrolatum (UNII: 4T6H12BN9U)  
white wax (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55550-902-210.9 g in 1 POUCH; Type 0: Not a Combination Product01/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/14/2020
Labeler - Total Resources International (790160535)

Revised: 1/2020
Document Id: 62f5795b-2608-41e4-bef8-36cc3c6cb77f
Set id: b971cc41-fe23-4be3-9564-e46d55df1d68
Version: 1
Effective Time: 20200114
 
Total Resources International