ORAJEL- benzocaine strip
BioFilm
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.
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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 • more than directed • for more than 7 days unless directed by a physician or healthcare provider • for teething • in children under 12 years of age
Stop use and ask a phyisican if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs
Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away
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 Information • do not use if pouch is torn or cut prior to opening • do not use continously • for best results, avoid drinking warm beverages or eating for at least one hour after applying the product
acid blue 9, glycerin, PEG-8, PEG-90, polycarbophil, potassium sorbate, pullulan, PVP, titanium dioxide, water.
Questions • call us at 800 952 5080 Monday through Friday 9am to 5pm or visit our website at www orajel com
#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
ORAJEL
benzocaine strip |
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Labeler - BioFilm (734555951) |
Registrant - Church & Dwight Co., Inc. (001211952) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
BioFilm | 734555951 | manufacture(72337-776) |