Orajel Cold Sore Touch Free - Single Dose

Orajel Cold Sore Touch Free - Single Dose
SPL v5
SPL
SPL Set ID ce40829e-941f-2548-e053-2995a90a1e0e
Route
TOPICAL
Published
Effective Date 2021-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg) Benzocaine (50 mg)
Inactive Ingredients
Water Isopropyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-01

Description

Benzalkonium chloride Benzocaine

Purpose

Benzalkonium chloride 0.13% ...................................................Topical Antiseptic Benzocaine 5% .........................................................................Topical Anesthetic


Medication Information

Purpose

Benzalkonium chloride 0.13% ...................................................Topical Antiseptic

Benzocaine 5% .........................................................................Topical Anesthetic

Description

Benzalkonium chloride Benzocaine

Uses

to treat cold sores/fever blisters

Section 50565-1

Keep out of reach of children.In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a dentist or physician if•condition persists or worsens •symptoms persist for more than 7 days

Section 50567-7

When using this productyou may feel a brief stinging when you apply it. The sting should go away in a short time.

Section 50569-3

Ask a physician if•used to treat deep or puncture wounds, animal bites or serious burns •you are pregnant or nursing a baby

Section 50570-1

Do not use•in the eyes •over large areas of the body •if you are allergic to any ingredient in this product •more than 3 times per day •longer than 1 week unless directed by a physician •for teething •in children under 2 years of age

Section 51945-4

NEW

LOOK

#1 ORAL PAIN

RELIEF BRAND

FOR ADULTS

BONUS

50% MORE

Orajel™

COLD SORE

PROVIDES IMMEDIATE, TARGETED PAIN RELIEF

LIQUID

FORMULA

TOPICAL ANTISEPTIC

TOPICAL ANESTHETIC

CONTAINS 6 TREATMENT VIALS

NET 0.12 FL OZ (3.5 mL) TOTAL

Warnings

For external use only. Flammable, keep away from fire or flame. Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: ​•pale, gray, or blue colored skin (cyanosis) •headache •rapid heart rate •shortness of breath •dizziness or lightheadedness •fatigue or lack of energy​

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

Directions

•slide-off to remove the protective blue paper cover and slide it on the other end - opposite the white applicator tip •squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap •hold with the white applicator tip down to allow the medication to saturate the tip •to minimize pain during application gently touch the site of the cold sore with the saturated applicator tip •Once the area is numb, rub the site of the cold sore and the surrounding area. Rub firmly to allow the treatment to deeply penetrate the skin •to treat most cold sores, multiple treatments may be required •discard after use •for best result ensure that lip area is free of lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick

Adults and children 2 years of age and older Do not use more than 3 times per day
Children between 2 and 12 years of age Ask a doctor before use. Should be supervised in the use of this product
Children under 2 years of age Do not use

Other Information

•store at room temperature • the ingredients in toothpaste, soft drinks, and some fruit juices can deactivate the active ingredient in this product •for best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for at least one hour after applying the drug •do not use if package is torn, cut or otherwise damaged

Active Ingredients

Benzalkonium chloride

Benzocaine

Inactive Ingredients

isopropyl alcohol (70% v/v), water

Questions Or Comments?

call us at 1-800-952-5080M-F 9am-5pm ET or visit our website at www.orajel.com


Structured Label Content

Uses

to treat cold sores/fever blisters

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a dentist or physician if•condition persists or worsens •symptoms persist for more than 7 days

Section 50567-7 (50567-7)

When using this productyou may feel a brief stinging when you apply it. The sting should go away in a short time.

Section 50569-3 (50569-3)

Ask a physician if•used to treat deep or puncture wounds, animal bites or serious burns •you are pregnant or nursing a baby

Section 50570-1 (50570-1)

Do not use•in the eyes •over large areas of the body •if you are allergic to any ingredient in this product •more than 3 times per day •longer than 1 week unless directed by a physician •for teething •in children under 2 years of age

Section 51945-4 (51945-4)

NEW

LOOK

#1 ORAL PAIN

RELIEF BRAND

FOR ADULTS

BONUS

50% MORE

Orajel™

COLD SORE

PROVIDES IMMEDIATE, TARGETED PAIN RELIEF

LIQUID

FORMULA

TOPICAL ANTISEPTIC

TOPICAL ANESTHETIC

CONTAINS 6 TREATMENT VIALS

NET 0.12 FL OZ (3.5 mL) TOTAL

Purpose

Benzalkonium chloride 0.13% ...................................................Topical Antiseptic

Benzocaine 5% .........................................................................Topical Anesthetic

Warnings

For external use only. Flammable, keep away from fire or flame. Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: ​•pale, gray, or blue colored skin (cyanosis) •headache •rapid heart rate •shortness of breath •dizziness or lightheadedness •fatigue or lack of energy​

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

Directions

•slide-off to remove the protective blue paper cover and slide it on the other end - opposite the white applicator tip •squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap •hold with the white applicator tip down to allow the medication to saturate the tip •to minimize pain during application gently touch the site of the cold sore with the saturated applicator tip •Once the area is numb, rub the site of the cold sore and the surrounding area. Rub firmly to allow the treatment to deeply penetrate the skin •to treat most cold sores, multiple treatments may be required •discard after use •for best result ensure that lip area is free of lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick

Adults and children 2 years of age and older Do not use more than 3 times per day
Children between 2 and 12 years of age Ask a doctor before use. Should be supervised in the use of this product
Children under 2 years of age Do not use

Other Information (Other information)

•store at room temperature • the ingredients in toothpaste, soft drinks, and some fruit juices can deactivate the active ingredient in this product •for best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for at least one hour after applying the drug •do not use if package is torn, cut or otherwise damaged

Active Ingredients (Active ingredients)

Benzalkonium chloride

Benzocaine

Inactive Ingredients (Inactive ingredients)

isopropyl alcohol (70% v/v), water

Questions Or Comments? (Questions or comments?)

call us at 1-800-952-5080M-F 9am-5pm ET or visit our website at www.orajel.com


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)