CARMEX COLD SORE TREATMENT EXTERNAL ANALGESIC- benzocaine cream 
Carma Laboratories, 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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CARMEX COLD SORE treatment External Analgesic

CARMEX COLD SORE treatment External Analgesic

Active Ingredient

Benzocaine 10%

Purpose

External Analgesic / Anti-Itch

Uses

Warnings


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

cyclomethicone, polyethylene glycol 600, dimethicone, silica, petrolatum, phenyl trimethicone, PEG/PPG-19/19 dimethicone, mica, peg 12 dimethicone, titanium dioxide, polyurethane-40, menthol, tin oxide

CARMEX COLD SORE treatment External Analgesic 2g (10210-0012-0)

InnerLabel

OuterLabel

CARMEX COLD SORE TREATMENT EXTERNAL ANALGESIC 
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MENTHOL (UNII: L7T10EIP3A)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0012-02 g in 1 TUBE; Type 0: Not a Combination Product05/28/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/28/2014
Labeler - Carma Laboratories, Inc. (006090153)
Establishment
NameAddressID/FEIBusiness Operations
Carma Laboratories, Inc.006090153manufacture(10210-0012)

Revised: 10/2019
Document Id: 95710336-9d59-36ae-e053-2a95a90a2233
Set id: 6d91a6e1-02b6-45da-8ef2-b8a8aa23d31a
Version: 2
Effective Time: 20191021
 
Carma Laboratories, Inc.