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

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

Drug Labeling and Warnings

CARMEX Multi-Symptom 3 in 1 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]

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0048
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	446.9 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0048-1	1 in 1 BLISTER PACK	07/01/2020
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	07/01/2020

Labeler - Carma Laboratories, Inc. (006090153)