Active Ingredient - Oral Pain Relief
Benzocaine 20%
Adventure Medical Kits Dental Medic
FDA Label NDC 44224-0102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tender Corporation for the product Adventure Medical Kits Dental Medic (NDC 44224-0102). 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 active ingredient - oral pain relief, purpose - oral pain relief, uses - oral pain reliever, warnings - oral pain relief, directions - oral pain relief, other information - oral pain relief, inactive ingredients - oral pain relief, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose - Oral Pain Relief
Oral Pain Reliever
Uses - Oral Pain Reliever
Temporarily relieves pain caused by: toothache, dental work, minor irritation or injury of the mouth and gums, canker sores, cheek bites, gum sores, and denture irritation.
Warnings - Oral Pain Relief
For oral use only. Avoid contact with eyes.
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 due to the possibility of anaphylactic shock.
When using this product
Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.
Keep out of reach of children
If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions - Oral Pain Relief
Adults and children 2 years and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.
Consult a dentist or doctor for use on children under 2 years of age
Children under 12 years of age should be supervised in the use of this product
Other Information - Oral Pain Relief
Do not use if packet is torn, cut, or opened
Store at room temperature, 15° to 30°C (59° to 86°F)
Avoid contact with eyes
Inactive Ingredients - Oral Pain Relief
PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid
Keep Out Of Reach Of Children
Keep out of Reach of Children
Adventure Medical Kits Dental Medic
Oral Pain Relief (Saf0l 0001 02)
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