Label: FINAFTA MULTIORAL- benzocaine spray
- NDC Code(s): 58593-782-02
- Packager: Efficient Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
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 December 2, 2021
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- ACTIVE INGREDIENT
- PURPOSE
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WARNINGS
Warnings: Do not exceed recommended dosage
Methemoglobinemia warning: Use of this product may cause mthemoglobinemia, a serious condition that must be treated promptyly because it reduces the amount of oxygen carried in the 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
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of enegry
Allegry alert
do not use this product if you have a history of allergy to local anesthetics such as prcaine, butacaine, bezocaine, or other "caine" anesthetics.
Do not use- for teething
- in children under 2 years of age
Consult a doctor promptly if:
sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens. If sore throat is sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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DOSAGE & ADMINISTRATION
DIRECTIONS:
For children over 12 years of age and Adults
• Apply Finafta® MultiOral Spray up to 4 times daily to affected areas of the mouth, gums or mucus membranes (mouth and throat).- Allow to remain in place at least 1 minute and then spit out.
• Close bottle tightly after each use.
- Children under 12 years of age: Do not use.
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FINAFTA MULTIORAL
benzocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-782 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 7.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) METHYLPARABEN (UNII: A2I8C7HI9T) PEPPERMINT OIL (UNII: AV092KU4JH) PHOSPHORIC ACID (UNII: E4GA8884NN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-782-02 1 in 1 CARTON 09/01/2004 1 59 mL in 1 BOTTLE, SPRAY; 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 09/01/2004 Labeler - Efficient Laboratories Inc. (969044932) Establishment Name Address ID/FEI Business Operations Dextrum Laboratories Inc. 007392322 manufacture(58593-782)
