Finafta
Finafta Multioral
cb027ab8-4175-4cc0-a73e-991dfb113df9
HUMAN OTC DRUG LABEL
Sep 23, 2025
Dextrum Laboratories Inc.
DUNS: 007392322
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
USES
For the temporary relief of occasional minor irritation, pain, sore mouth, pain associated with canker sores or pain due to minor irritation of the mouth and gums cause by dentures or othodontic applicances.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: (%) Purpose
Benzocaine USP 7.5% ................ Oral Anesthetic/Analgesic
OTC - PURPOSE SECTION
**Purpose**
Oral Anesthetic/Analgesic
WARNINGS SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
**Keep Out of reach of children.**In case of accidental overdose, get medical
help or contact a Poison
Control Center right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
**If pregnant or breastfeeding,**ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
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.
INACTIVE INGREDIENT SECTION
Inactive ingredients:
Benzalkonium chloride, glycerin, methylparaben, peppermint oil, phosphoric acid, propylene glycol, propylparaben and purified water.
OTC - QUESTIONS SECTION
QUESTIONS OR COMMENTS?
305-805-3456
Monday-Friday (9 a.m.- 5 p.m. EST)
www.efficientlabs.com