SALIVACAINE- benzocaine powder, for solution 
Forward Science Technologies LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SalivaCAINE

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.

oral pain reliever

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 
benzocaine powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70275-406
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE150 mg  in 3000 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70275-406-0330 in 1 CARTON02/24/2017
1150 mg in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/24/2017
Labeler - Forward Science Technologies LLC (079212068)
Establishment
NameAddressID/FEIBusiness Operations
Forward Science Technologies LLC079212068manufacture(70275-406)

Revised: 1/2020
Document Id: 7bacbad2-a161-21c0-e053-2991aa0a19f2
Set id: 4793e9d8-25fc-00b4-e054-00144ff88e88
Version: 4
Effective Time: 20200117
 
Forward Science Technologies LLC