Otc - Active Ingredient
Allantoin 0.5%
Benzocaine 20%
Camphor 3%
Dimethicone 2%
Menthol 1%
White petrolatum 64%
Orajel Cold Sore Moisturelock Cream
FDA Label NDC 10237-761
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 Cold Sore Moisturelock (NDC 10237-761). 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 - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Allantoin - Skin protectant
Benzocaine - Topical anesthetic
Camphor - Topical analgesic
Dimethicone - Skin protectant
Menthol - Topical analgesic
White petrolatum - Skin protectant
Indications & Usage
Uses • temporarily relieves pain and dryness; softens crusts (scabs) associated with • cold sores • fever blisters
Warnings
For external use only.
Allergy alert: do not use 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
Otc - When Using
When using this product • do not get into eyes
Otc - Stop Use
Stop use and ask a physician if • conditions worsens • symptoms do not improve in 7 days • symptoms clear up and occur again within a few days • swelling, rash or fever develops • irritation, pain or redness persists or worsens
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact Poison Control Center right away.
Directions
• squeeze tube to dispense • blend well until green tint disappears • rub in gently
Adults and children 2 years of age and older | Apply to affected area not more than 3 to 4 times daily
Children under 12 years of age | Should be supervised in the use of this product
Children under 2 years of age | Ask a physician
Other information • do not use if the package is torn, cut or otherwise damaged • store at 15-30°C (59-86°) under dry conditions • this is a personal care item and should be used by one individual only
Inactive Ingredient
Inactive Ingredients caprylic/capric triglyceride, Prunella vulgaris leaf extract. propylene glycol, water, tocopheryl acetate, retinyl palmitate, Zea mays (corn) oil, tocopherol, cholecalciferol, titanium dioxide, yellow 5 lake, iron oxides, blue 1 lake
Otc - Questions
Questions or comments call us at 800 952 5080 Monday through Friday 9 to 5 ET or visit www orajel com
Package Label.Principal Display Panel
Orajel
Instan Pain Relief
FOR COLD SORES
MOISTURELOCK FORMULA
Helps Speed Healing
Treats 6 Symptoms:
1 Pain
2 Itching
3 Redness
4 Scabbing
5 Cracking
6 Dryness
PLUS
Helps Minimize Appearance of Cold Sores
Topical Anesthetic/Topical
Analgesic/Skin Protectant
NET WT 0.105 OZ (3g)
* Please review the disclaimer below.
