SCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC- lidocaine, benzalkonium chloride gel 
CCA Industries, 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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Scar Zone Burn Gel Topical Analgesic & Antiseptic

Drug Facts

Active Ingredients

Lidocaine 2.00%
Benzalkonium Chloride 0.13%

Purpose

Topical Analgesic/Anesthetic
First Aid Antiseptic

Use

For temporary relief of pain or discomfort, for first degree burns or superficial second degree burns and to help prevent infection in: minor burns, cuts, scrapes.

Warnings

Do not use 

  • for more than 1 week
  • in or near eyes
  • over an area larger than the palm of your hand

Ask a doctor before use if 

burn in severe

Ask a doctor or pharmacist before use if

  • you have a history of heart disease or serious burns

Stop use and ask a doctor if 

increased redness or weeping or pain persist or clears up and occurs again within a few days

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years and over

Inactive Ingredients

allantoin, allium cepa (onion) bulb extract, aloe barbadensis leaf juice, benzyl alcohol, butylene glycol, calophyllum tacamahaca (tamanu) seed oil, camellia sinensis leaf extract, centella asiatica extract, citric acid, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylisothiazolinone, phenoxyethanol, phytonadione, polysorbate 60, propylene glycol, sodium polyacrylate, water (aqua).

Questions or Comments?

Package Labeling:

Label2

SCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC 
lidocaine, benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-6174
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ONION (UNII: 492225Q21H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHYTONADIONE (UNII: A034SE7857)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-6174-51 in 1 BOX03/15/2019
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/14/2010
Labeler - CCA Industries, Inc. (106771041)

Revised: 12/2022
Document Id: eff1461a-d8e5-12f7-e053-2995a90a7cc2
Set id: fc53b5c0-df17-4ec1-8804-8fd01ec6a6cb
Version: 7
Effective Time: 20221216
 
CCA Industries, Inc.