CARMEX MULTI-SYMPTOM 3 IN 1 COLD SORE TREATMENT EXTERNAL ANALGESIC SKIN PROTECTANT- benzocaine, white petrolatum cream 
Carma Laboratories, Inc.

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CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant

Drug Facts

Active Ingredients

Benzocaine 10%

White Petrolatum 44.69%

Purpose

External Analgesic

Skin Protectant

Uses

• For temporary relief of pain and itching associated with symptoms of fever blisters and cold sores • Helps prevent and protect dry, chapped lips

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” anesthetic

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

Do not use on

• deep or puncture wounds • animal bites • serious burns

When using this product

keep out of eyes. Rinse with water to remove. Do not exceed recommended dosage.

Keep out of reach of children.

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

Directions

Using clean, dry hands apply 1 to 2 small dollops of Carmex Cold Sore product to the tip of the finger and gently apply and spread evenly to the surface of the cold sore to ensure even coverage over areas of redness. Wash hands thoroughly after application.

 Adults and children 2 years of age and older Apply to affected area (lips) not more than 3 to 4 times daily
 Children 2-12 years of age Should be supervised in use of this product
 Children under 2 years of age Ask a doctor

Other Information

• Protect this product from excessive heat and direct sunlight • Store between 0° C to 28° C (32° F to 82.4° F)

Inactive Ingredients:

Polyethylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Titanium Dioxide, Behenyl Olivate, PPG-51 SMDI Copolymer, Mica, Synthetic Wax, Calcium Silicate, Flavor, Isopropyl Titanium Triisostearate, Silica, Tin Oxide, Iron Oxides (C.I 77491, C.I 77492, C.I. 77499)

Package Labeling:

Label4Label5

CARMEX MULTI-SYMPTOM 3 IN 1 COLD SORE TREATMENT EXTERNAL ANALGESIC SKIN PROTECTANT 
benzocaine, white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0048
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE100 mg  in 1 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (BENZOCAINE - UNII:U3RSY48JW5) WHITE PETROLATUM446.9 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BEHENYL OLIVATE (UNII: NGS1GGK4GW)  
PPG-51/SMDI COPOLYMER (UNII: KQ9JG3O3YA)  
MICA (UNII: V8A1AW0880)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0048-11 in 1 BLISTER PACK07/01/2020
12 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/01/2020
Labeler - Carma Laboratories, Inc. (006090153)

Revised: 10/2023
Document Id: 08883637-b8d6-23dc-e063-6394a90ae9f7
Set id: bbf0abcd-b7d6-b5e4-e053-2995a90a5240
Version: 2
Effective Time: 20231025
 
Carma Laboratories, Inc.