FDA Label for 20/20 Topical Anesthetic
View Indications, Usage & Precautions
20/20 Topical Anesthetic Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Dental Anesthetics. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Storage conditions: 55° to 78° Fahrenheit in a dry place. Keep foil pouch for information. KEEP AWAY FROM LIGHT
Distributed by:
Advanced
DENTAL ANESTHETICS
Active Ingredient
Benzocaine 20%
Purpose
Oral pain reliever
Use
Temporary relief of oral pain
Otc - Ask Doctor/Pharmacist
Consult a physician or qualified health care professional prior to using this product if you have any medical conditions, or if you are using any prescription drug.
Allergy Alert
do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
This carrying case may present a choking hazard. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.
Stop Use And Ask Doctor If
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
Directions
Not for use by individuals under 12 years of age.
Dosage: 1 strip, not more than 4 per day
- Remove 1 strip from carrying case.
- Place strip onto area of desired anesthesia
- Allow strip to dissolve completely
Inactive Ingredients
Hydroxypropyl Methyl Cellulose, Gylcerine, Peppermint Oil Flavor, Gum Arabic, Sodium Carboxy Methyl Cellulose, Sucralose, Polysorbate 80, Sodium Copper Chlorophyllin.
Principal Display Panel - 24 Strip Pouch Label
Active Ingredient: Benzocaine 20%
20/20
Topical Anesthetic Strip
24 STRIPS
* Please review the disclaimer below.