Active Ingredient
Benzocaine 5% (w/v)
Purpose: oral pain reliever
Salivacaine
FDA Label NDC 70275-406
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Forward Science Technologies Llc for the product Salivacaine (NDC 70275-406). 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, uses, methemoglobinemia warning, allergy alert, sore throat warning, do not use, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For temporary relief of occasional minor oral
irritation, oral pain, and sore mouth.
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 in 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 • dizziness or lightheadedness
• rapid heart rate • shortness of breath
• fatigue 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 any other ‘caine’ anesthetics. If a skin reaction occurs, stop use and seek
medical help right away.
Sore Throat Warning
If sore throat is severe, persists for more than
2 days, is accompanied or followed by fever
headache, rash, nausea, or vomiting, consult a
doctor promptly. If sore mouth symptoms do
not improve in 7 days, see your dentist or
doctor promptly.
Do Not Use
Do not use
• for teething
• in children under 2 years of age
Keep Out Of Reach Of Children
Keep out of reach of children
Directions
Adults and children 2 years of age and older:
Mix packet with 0.1oz water and apply the rinse to the affected area. Gargle, swish around in the mouth, or allow to remain in place 1 minute then Spit Out.
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 the product.
Children under 2 years of age: do not use
Inactive Ingredients
Calcium Chloride, Dibasic Sodium Phosphate, Monobasic Sodium
Phosphate, Silicon Dioxide, Sodium Chloride
Questions
Call 1-855-696-7254 (M - F 8:30 - 5:30 CST)
You may also report side effects to this phone number.
Otc - Purpose
oral pain reliever
Package Label.Principal Display Panel
NDC 70275-0406-03
SalivaCAINE
Oral Pain Reliever
(Benzocaine 5%)
30 Packets Dissolving Powder
Mix with water before use
Benzocaine 150mg/0.1oz
418mg per packet - 12.54g total
Salivacaine_box_pkts_3qtr_rt.jpg (Salivacaine Box Pkts 3qtr Rt)
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