Label: ORAJEL FOR COLD SORES SINGLE DOSE- benzalkonium chloride, benzocaine liquid
- NDC Code(s): 10237-741-04
- 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.
Updated April 20, 2012
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
Benzalkonium chloride, 0.13%Close
Cold Sore / Fever Blister Treatment; Topical AntisepticClose
Pain Relief During Applications
- INDICATIONS & USAGE
- to treat cold sores / fever blisters
- to help guard against infection
For external use only. Flammable, keep away from fire or flame.
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" anestheticsDo not use
- in the eyes
- over large areas of the body
- if you are allergic to any ingredient in the product
- more than 3 times per day
- longer than one week unless directed by a physician
- condition persists or worsens
- symptoms persist for more than 7 days
- used to treat deep or puncture wounds, animal bites, or serious burns
- you are pregnant or nursing a baby
- KEEP OUT OF REACH OF CHILDREN
KEEP OUR OF REACH OF CHILDREN
In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away.Close
- DOSAGE & ADMINISTRATION
Adults and children over 2 years of age:
- Clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics including lipstick using only warm water or alcohol
- 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, usually one treatment is enough. If your symptoms go away and then return later, apply another dose for the second cold sore
- Do not use more than 3 times per day
- Discard after use.
- Store at room temperature
- The ingredients in toothpaste, soft drinks, and some fruit juices can de-activate 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.
- INACTIVE INGREDIENT
isopropyl alcohol (70% v/v), water
Questions or coments? call us at 1-800-952-5080 M-F ET or visit our website at www.orajel.comClose
- PRINCIPAL DISPLAY PANEL
Instant Pain Relief
FOR COLD SORES
ONE DAY, ONE DOSE,
Patented Cold Sore Treatment
CONTAINS 2 ONE DAY TREATMENT VIALS TOPICAL ANTISEPTIC/TOPICAL ANESTHETIC
NET 0.04 FL OZ (1.2 mL) Total TOUCH-FREE APPLICATOR
- INGREDIENTS AND APPEARANCE
ORAJEL FOR COLD SORES SINGLE DOSE
benzalkonium chloride, benzocaine liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-741 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 mg in 1 mL BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 0.5 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:10237-741-04 2 in 1 PACKAGE 1 0.6 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/01/2012 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations James Alexander Corporation 040756421 manufacture Establishment Name Address ID/FEI Business Operations Berkeley Contract Packaging, LLC 807293576 pack