SALIVACAINE- benzocaine powder, for solution

SalivaCAINE by

Drug Labeling and Warnings

SalivaCAINE by is a Otc medication manufactured, distributed, or labeled by Forward Science Technologies LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzocaine 5% (w/v)

Purpose: oral pain reliever

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.

PURPOSE

oral pain reliever

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

INGREDIENTS AND APPEARANCE

SALIVACAINE 
benzocaine powder, for solution

Product 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)