Label: SALIVACAINE- benzocaine powder, for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 17, 2020

If you are a consumer or patient please visit this version.

  • 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

    salivacaine_box_pkts_3qtr_rt.jpg

  • INGREDIENTS AND APPEARANCE
    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)