BURN TREATMENT- benzalkonium chloride, lidocaine hydrochloride cream 
CMC Group Inc.

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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Burn Treatment

Drug Facts

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Purpose

First aid antiseptic

Pain relieving cream

Uses

Warnings

For external use only.

Do not use

• in the eyes  • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

• deep or puncture wounds • animal bites • serious burns.

Stop use and ask a doctor if

• the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reah of children.

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

Directions

Other information

Store at room temperature

Inactive ingredients

glycerin monostearate, glycerol, purified water

Package Labeling:

Burn treatment

BURN TREATMENT 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49687-0014-010 in 1 KIT08/06/2016
10.9 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/06/2016
Labeler - CMC Group Inc. (005583328)

Revised: 1/2020
Document Id: 9d36106e-2989-a8aa-e053-2a95a90aae1d
Set id: 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40
Version: 4
Effective Time: 20200128
 
CMC Group Inc.