Label: ORAJEL- benzocaine strip
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Contains inactivated NDC Code(s)
NDC Code(s): 72337-776-01 - Packager: BioFilm
- 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 January 22, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
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 to the 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 • fatique 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
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions • make sure hands are dry and free of moisture as strip may be sticky/tacky • tear open pouch and remove blue strip
Adults and children 12 years or age and over: Using either side of strip, immediately place directly onto the affected area keeping tongue and lips clear. Gently press for 5-10 seconds until strip adheres to the area. Strip will stay in place and dissolve slowly in mouth for up to 1 hour for duration of treatment. Use up to 4 times daily or as directed by a physician or healthcare provider.
Children under 12 years of age: Do not use
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
#1 ORAL PAIN
Reliever Brand
For Toothache
NEW!
SLOW DISSOLVING STRIPS
For Lasting Relief
Orajel™
TOOTHACHE STRIPS
MEDICATED FOR TOOTHACHE & GUM
INSTANT & TARGETED PAIN RELIEF
• Long-Lasting Pain Relief
•Maximum level of Pain Relief with 15mg Benzocaine*
•Stays in place for Targeted Relief
•Soothes gums with Menthol
Cool Mint Taste
8 STRIPS
Individually Wrapped
Oral Pain Reliever
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INGREDIENTS AND APPEARANCE
ORAJEL
benzocaine stripProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72337-776 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 25 mg in 1 g BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K90 (UNII: RDH86HJV5Z) POLYCARBOPHIL (UNII: W25LM17A4W) ACID BLUE 9 AMMONIUM (UNII: 86R7G3C26F) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PULLULAN (UNII: 8ZQ0AYU1TT) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72337-776-01 1 in 1 CARTON 01/15/2019 1 8 g in 1 PACKAGE; 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 11/05/2018 Labeler - BioFilm (734555951) Registrant - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations BioFilm 734555951 manufacture(72337-776)