FDA Label for Oral Pain Relief
View Indications, Usage & Precautions
Oral Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Kareway Product, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Warnings
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
Otc - Do Not Use
Do not use
more than directed for more than 7 days unless told to do so by a dentist or doctor
Otc - Ask Doctor
Stop use and ask a doctor if
swelling, rash or fever develops; irritation, pain or redness persists or worsens; symptoms do not improve in 7 days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children:
in case of overdose, get medical help or contact a Poison Control Center right away
Directions
Directions do not use if tube tip is cut prior to opening; cut open tip of tube on score mark
Adults and children 2 years of age and over Apply a small amount of product to the cavity and around gum surrounding the teeth.
Use up to 4 times daily or as directed by a dentist or doctor
Children under 12 years of age Should be supervised in the use of this product
Children under 2 years of age Ask a dentist or doctor
Other information
This preparation is intended for use in case of toothache, only as a temporary expedient until a dentist can be consulted;
do not use continuously
Inactive Ingredients
Inactive ingredients polyethylene glycol, glycerin, sodium saccharin, sorbic acid, flavor
Active Ingredient (In Each Gram)
Benzocaine 20%
Purpose
Oral Pain Reliever
Uses
temporarily relieves pain due to toothaches
Package Label.Principal Display Panel
Orajel gel
Instant Pain Relief
for TOOTHACHE
MAXIMUM STRENGTH
NE WT 0.42 OZ (11.9 g) ORAL PAIN RELIEVER BENZOCAINE 20%
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