CARMEX COLD SORE TREATMENT EXTERNAL ANALGESIC- benzocaine cream

CARMEX COLD SORE treatment External Analgesic by

Drug Labeling and Warnings

CARMEX COLD SORE treatment External Analgesic by is a Otc medication manufactured, distributed, or labeled by Carma Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CARMEX COLD SORE treatment External Analgesic

Active Ingredient

Benzocaine 10%

Purpose

External Analgesic / Anti-Itch

Uses

• For the temporary relief of symptoms of cold sores and fever blisters

Warnings

• For external use only
• Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics
• When using this product keep out of eyes. Rinse with water to remove.
• Do not exceed recommended dosage.
• Stop use and ask a doctor or dentist if
• • cold sore symptoms do not improve in 7 days
• • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

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

Directions

• adults and children 2 years of age and older: apply to affected area (lips) not more than 3 to 4 times daily

• children under 2 years of age: ask a doctor

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)

INGREDIENTS AND APPEARANCE

CARMEX COLD SORE TREATMENT EXTERNAL ANALGESIC 
benzocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0012-0	2 g in 1 TUBE; Type 0: Not a Combination Product	05/28/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/28/2014

Labeler - Carma Laboratories, Inc. (006090153)

Establishment
Name	Address	ID/FEI	Business Operations
Carma Laboratories, Inc.		006090153	manufacture(10210-0012)