Label: ORAJEL FOR COLD SORES SINGLE DOSE- benzalkonium chloride, benzocaine liquid
- NDC Code(s): 10237-756-03, 10237-756-04
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 7, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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Warnings
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 beat, 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
- Do not use
- Stop use and ask a dentist or physician if
- Ask a physician if
- When using this product
- Keep out of reach of children
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Directions
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 results ensure that lip area is free of lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick
Adults and children over 2 years of age: Do not use this more than 3 times per day
Children between 2 year 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 Orajel Single Dose.
- For best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for one hour after applying the drug.
- Do not use if package is torn, cut or otherwise damaged
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
ORAJEL FOR COLD SORES SINGLE DOSE
benzalkonium chloride, benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-756 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-756-04 4 in 1 PACKAGE 07/01/2012 09/30/2024 1 2.4 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product 2 NDC:10237-756-03 2 in 1 PACKAGE 07/01/2012 12/18/2019 2 1.2 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/01/2012 09/30/2024 Labeler - Church & Dwight Co., Inc. (001211952)
