Label: 20/20 TOPICAL ANESTHETIC- benzocaine strip
- NDC Code(s): 76484-948-24
- Packager: Advanced Dental Anesthetics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated May 8, 2012
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Oral pain relieverClose
Temporary relief of oral painClose
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.
do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
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
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
Storage conditions: 55° to 78° Fahrenheit in a dry place. Keep foil pouch for information. KEEP AWAY FROM LIGHTClose
- Inactive ingredients
Hydroxypropyl Methyl Cellulose, Gylcerine, Peppermint Oil Flavor, Gum Arabic, Sodium Carboxy Methyl Cellulose, Sucralose, Polysorbate 80, Sodium Copper Chlorophyllin.Close
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 24 Strip Pouch Label
Active Ingredient: Benzocaine 20%
Topical Anesthetic Strip
- INGREDIENTS AND APPEARANCE
20/20 TOPICAL ANESTHETIC
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76484-948 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE 2208 (3 MPA.S) (UNII: 9H4L916OBU) 18.44 mg HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) ACACIA (UNII: 5C5403N26O) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SUCRALOSE (UNII: 96K6UQ3ZD4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O) Product Characteristics Color GREEN (Light Green) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76484-948-24 1 in 1 POUCH 1 24 in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part356 02/28/2012 Labeler - Advanced Dental Anesthetics (969804223) Establishment Name Address ID/FEI Business Operations Atlas Operations Inc 946369055 MANUFACTURE, PACK, LABEL