- Active ingredient
- Uses
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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
- Sore throat warning
- Do Not Use
- Keep out of reach of children
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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
- Questions
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SALIVACAINE
benzocaine powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70275-406 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 150 mg in 3000 mg Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM CHLORATE DIHYDRATE (UNII: BBB2RG413E) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70275-406-03 30 in 1 CARTON 02/24/2017 1 150 mg in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/24/2017 Labeler - Forward Science Technologies LLC (079212068) Establishment Name Address ID/FEI Business Operations Forward Science Technologies LLC 079212068 manufacture(70275-406)