Label: ORAJEL COLD SORE TOUCH FREE - SINGLE DOSE- benzalkonium chloride, benzocaine liquid
- NDC Code(s): 10237-798-35
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 2, 2024
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- Drug Facts
- Active ingredients
- Purpose
- Uses
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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
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
Stop use and ask a dentist or physician if •condition persists or worsens •symptoms persist for more than 7 days
Ask a physician if •used to treat deep or puncture wounds, animal bites or serious burns •you are pregnant or nursing a baby
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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
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
ORAJEL COLD SORE TOUCH FREE - SINGLE DOSE
benzalkonium chloride, benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-798 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 WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-798-35 6 in 1 PACKAGE 09/01/2021 1 3.5 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 DRUG M016 09/01/2021 Labeler - Church & Dwight Co., Inc. (001211952)
