Otc - Active Ingredient
Benzocaine 20%
White petrolatum 73.64%
Orajel For Cold Sores Double Medicated, Cream
FDA Label NDC 10237-797
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Orajel For Cold Sores Double Medicated, Cream (NDC 10237-797). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - questions, otc - purpose, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Questions
Questions or comments? call us at 1-800-952-5080 M-F 9am-5pm or visit our website at www.orajel.com
Otc - Purpose
Topical anesthetic
Skin protectant
Indications & Usage
Use temporarily relieves pain, itching and dryness; softens crusts (scabs) associated with • cold sores • fever blisters
Warnings
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
Otc - Do Not Use
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & 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
Inactive Ingredient
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
Package Label.Principal Display Panel
#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)
Label.jpg (Label)
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