Carmex Multi-symptom 3 In 1 Cold Sore Treatment External Analgesic Skin Protectant

Carmex Multi-symptom 3 In 1 Cold Sore Treatment External Analgesic Skin Protectant
SPL v2
SPL
SPL Set ID bbf0abcd-b7d6-b5e4-e053-2995a90a5240
Route
TOPICAL
Published
Effective Date 2021-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (100 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Titanium Dioxide Behenyl Olivate Ppg-51/smdi Copolymer Mica Calcium Silicate Isopropyl Titanium Triisostearate Silicon Dioxide Stannic Oxide Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-01

Description

Benzocaine 10% White Petrolatum 44.69%

Purpose

External Analgesic Skin Protectant


Medication Information

Purpose

External Analgesic

Skin Protectant

Description

Benzocaine 10% White Petrolatum 44.69%

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

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
Do Not Use On

• deep or puncture wounds • animal bites • serious burns

Other Information

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

Package Labeling:

Active Ingredients

Benzocaine 10%

White Petrolatum 44.69%

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)

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.

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


Structured Label Content

Uses

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

Purpose

External Analgesic

Skin Protectant

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

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
Do Not Use On (Do not use on)

• deep or puncture wounds • animal bites • serious burns

Other Information

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

Package Labeling:

Active Ingredients

Benzocaine 10%

White Petrolatum 44.69%

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)

When Using This Product (When using this product)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Ask A Doctor Or Dentist If (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


Advanced Ingredient Data


Raw Label Data

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