Label: BENZ O STHETIC- benzocaine spray
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-929-02 - Packager: Geritrex LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Drug Label Information
Updated September 28, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drugs Facts
- Uses
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Directions
May be used with extension tube for finer direct application. For adults and children 2 years and older anesthetic use in mouth or throat:
Pump spray 2-3 times up to 4 times. Repeat if needed for larger areas. Anesthetic effect is reached in 15-30 seconds. Children under 12 years of age should be supervised and use as directed by dentist/doctor. - INDICATIONS & USAGE
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Warnings
Do not use this product if patient has a history of allergy to local anesthetics
such as procaine, butacaine, benzocaine, or other “caine” anesthetics. Do not
spray into or near eyes. Do not inhale.Patient: When using extension tube, do not spray in the back of the throat
unless your dentist or doctor directed you to do so.When using this product:
- Avoid use near eyes
- Do not use more than recommended dosage
- Do not go beyond 7 days usage, unless directed by your doctor/dentist
Patient: Discontinue use and consult a physician if: sore mouth symptoms do
not improve in 5 days; irritation, pain, or redness persists or worsens;
swelling, rash, or fever develops. - Other Ingredients
- Other Information:
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS AND PRECAUTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BENZ O STHETIC
benzocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-929 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 11.8 g in 59 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PEPPERMINT OIL (UNII: AV092KU4JH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor CHERRY (CHERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-929-02 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/30/2017 Labeler - Geritrex LLC (112796248) Establishment Name Address ID/FEI Business Operations Geritrex LLC 112796248 manufacture(54162-929)