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
Oral Pain Relief
FDA Label NDC 67510-0058
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Oral Pain Relief (NDC 67510-0058). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings, otc - do not use, otc - ask doctor, otc - keep out of reach of children, directions, inactive ingredients, active ingredient (in each gram), purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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%
Carton Image (Oral.carton)
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