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Drug Facts
Storage conditions: 55° to 78° Fahrenheit in a dry place. Keep foil pouch for information. KEEP AWAY FROM LIGHT
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DENTAL ANESTHETICS
20/20
FDA Label NDC 76484-948
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Dental Anesthetics for the product 20/20 (NDC 76484-948). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, otc - ask doctor/pharmacist, allergy alert, otc - keep out of reach of children, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Principal Display Panel (24 Strip Pouch Label)
* Please review the disclaimer below.
