CARMEX COLD SORE treatment External Analgesic Skin Protectant

CARMEX COLD SORE treatment External Analgesic Skin Protectant by

Drug Labeling and Warnings

CARMEX COLD SORE treatment External Analgesic Skin Protectant 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 SKIN PROTECTANT- benzocaine, white petrolatum cream 
Carma Laboratories, Inc.

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CARMEX COLD SORE treatment External Analgesic Skin Protectant

Drug Facts

Active Ingredients

Benzocaine 10.0%

White Petrolatum 45.9%

Purpose

External Analgesic / Anti-Itch

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" anesthetics

Stop use and ask a doctor 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

• 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 sun
• Store between 0°C to 28°C (32°F to 82.4°F)

Inactive Ingredients

polyethylene glycol, HDI/trimethylol hexyllactone crosspolymer, mica, behenyl olivate, PPG-51 SMDI copolymer, titanium dioxide, synthetic wax, calcium silicate, silica, flavor, iron oxides (C.I. 77491), isopropyl titanium triisostearate

Package Labeling:

CARMEX COLD SORE TREATMENT EXTERNAL ANALGESIC SKIN PROTECTANT 
benzocaine, white petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	100 mg  in 1 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (BENZOCAINE - UNII:U3RSY48JW5)	WHITE PETROLATUM	459 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MICA (UNII: V8A1AW0880)
BEHENYL OLIVATE (UNII: NGS1GGK4GW)
PPG-51/SMDI COPOLYMER (UNII: KQ9JG3O3YA)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CALCIUM SILICATE (UNII: S4255P4G5M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0027-1	1 in 1 BLISTER PACK	03/02/2017	07/01/2022
1		2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/02/2017	07/01/2022

Labeler - Carma Laboratories, Inc. (006090153)

Revised: 12/2024

Document Id: 29119fd8-49f3-114e-e063-6294a90af6d4

34390-5

Set id: bada4108-4b3f-8ee6-e053-2995a90a9027

Version: 3

Effective Time: 20241212