Orajel For Cold Sores Double Medicated, Cream
b8699a40-8464-ca02-e053-2995a90a4260
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Benzocaine 20% White petrolatum 73.64%
Medication Information
Warnings and Precautions
Warnings
For external use only
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
Indications and Usage
Use temporarily relieves pain, itching and dryness; softens crusts (scabs) associated with • cold sores • fever blisters
Dosage and Administration
Directions
- cut open tube of tip on score mark
- Do not use if tip is cut prior to opening
Adults and Children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
Children betweem 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
Description
Benzocaine 20% White petrolatum 73.64%
Section 50565-1
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50570-1
Do not use
- more than directed
- for more than 7 days unless directed by a physician or healthcare provider
- for teething
- in children under 2 years of age
Section 51727-6
Inactive ingredients cholecalciferol, mineral oil, phenoxyethanol (and) hydroxyacetophenone (and) caprylyl glycol (and) water, propylene glycol, prunella vulgaris leaf extract, retinyl palmitate (vitamin A palmitate), tocopherol, tocopherol acetate (vitamin E acetate), zea mays (corn) oil
Section 51945-4
#1
ORAL PAIN
RELIVER
BRAND
FOR ADULTS
2 Active
Ingredients
Orajel
Instant Pain Relief
FOR COLD SORES
Fast-Acting Cream
DOUBLE MEDICATED
Relieves Pain & Itching
Moisturizing Barrier Stays in Place
Paraben Free
TOPICAL ANESTHETIC/SKIN PROTECTANT
NET WT 0.125 OZ (3.5 g)
Section 53413-1
Questions or comments?call us at 1-800-952-5080M-F 9am-5pm or visit our website at www.orajel.com
Section 55105-1
Topical anesthetic
Skin protectant
Section 55106-9
Benzocaine 20%
White petrolatum 73.64%
Structured Label Content
Indications and Usage (34067-9)
Use temporarily relieves pain, itching and dryness; softens crusts (scabs) associated with • cold sores • fever blisters
Dosage and Administration (34068-7)
Directions
- cut open tube of tip on score mark
- Do not use if tip is cut prior to opening
Adults and Children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
Children betweem 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
Warnings and Precautions (34071-1)
Warnings
For external use only
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
Section 50565-1 (50565-1)
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50570-1 (50570-1)
Do not use
- more than directed
- for more than 7 days unless directed by a physician or healthcare provider
- for teething
- in children under 2 years of age
Section 51727-6 (51727-6)
Inactive ingredients cholecalciferol, mineral oil, phenoxyethanol (and) hydroxyacetophenone (and) caprylyl glycol (and) water, propylene glycol, prunella vulgaris leaf extract, retinyl palmitate (vitamin A palmitate), tocopherol, tocopherol acetate (vitamin E acetate), zea mays (corn) oil
Section 51945-4 (51945-4)
#1
ORAL PAIN
RELIVER
BRAND
FOR ADULTS
2 Active
Ingredients
Orajel
Instant Pain Relief
FOR COLD SORES
Fast-Acting Cream
DOUBLE MEDICATED
Relieves Pain & Itching
Moisturizing Barrier Stays in Place
Paraben Free
TOPICAL ANESTHETIC/SKIN PROTECTANT
NET WT 0.125 OZ (3.5 g)
Section 53413-1 (53413-1)
Questions or comments?call us at 1-800-952-5080M-F 9am-5pm or visit our website at www.orajel.com
Section 55105-1 (55105-1)
Topical anesthetic
Skin protectant
Section 55106-9 (55106-9)
Benzocaine 20%
White petrolatum 73.64%
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:30.067522 · Updated: 2026-03-14T23:11:02.639613