Scar Zone Burn Topical Analgesic and Antiseptic

Product NDC
61543-6174
11-digit product format
615436174
Labeler code
61543
Product ID
61543-6174_eff1461a-d8e5-12f7-e053-2995a90a7cc2
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE, BENZALKONIUM CHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
CCA Industries, Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-06-14
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE
Active strength
0 g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61543-6174-5Scar Zone Burn Topical Analgesic and Antiseptic14 g in 1 TUBEGEL147
61543-6174-5Scar Zone Burn Topical Analgesic and Antiseptic1 in 1 BOXGEL17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7SCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
LIDOCAINEACTIVE INGREDIENT98PI200987SCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YSCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
LIDOCAINEACTIVE MOIETY98PI200987SCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
ALLANTOININACTIVE INGREDIENT344S277G0ZSCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
CENTELLA ASIATICAINACTIVE INGREDIENT7M867G6T1USCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFASCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
ONIONINACTIVE INGREDIENT492225Q21HSCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
PHYTONADIONEINACTIVE INGREDIENTA034SE7857SCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MSCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GSCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RSCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61543-6174SCAR ZONE BURN TOPICAL ANALGESIC AND ANTISEPTIC (LIDOCAINE, BENZALKONIUM CHLORIDE) GEL [CCA INDUSTRIES, INC.]7Legacy NDC, 2 package rows20221217_fc53b5c0-df17-4ec1-8804-8fd01ec6a6cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052429benzalkonium chloride 0.13 % / lidocaine 2 % Topical GelPSNfc53b5c0-df17-4ec1-8804-8fd01ec6a6cb7
1052431scar zone burn gel 2 % / 0.13 % Topical GelPSNfc53b5c0-df17-4ec1-8804-8fd01ec6a6cb7
1052431benzalkonium chloride 0.0013 MG/MG / lidocaine 0.02 MG/MG Topical Gel [Scar Zone Burn Relief]SBDfc53b5c0-df17-4ec1-8804-8fd01ec6a6cb7
1052429benzalkonium chloride 0.0013 MG/MG / lidocaine 0.02 MG/MG Topical GelSCDfc53b5c0-df17-4ec1-8804-8fd01ec6a6cb7
1052429benzalkonium chloride 0.13 % / lidocaine 2 % Topical GelSYfc53b5c0-df17-4ec1-8804-8fd01ec6a6cb7
1052431Scar Zone Burn Gel (lidocaine 2 % / benzalkonium chloride 0.13 % ) Topical GelSYfc53b5c0-df17-4ec1-8804-8fd01ec6a6cb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61543-6174-5615436174051 TUBE in 1 BOX (61543-6174-5) > 14 g in 1 TUBE1 tube2019-03-150000-00-00NoNoCurrent