Label: TOPEX- benzocaine spray, metered
- NDC Code(s): 0699-3100-02
- Packager: Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated December 20, 2017
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- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
WARNINGS AND PRECAUTIONS
Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if the patient in your care develops:
- pale, gray, or blue colored skin (cyanosis),
- rapid heart rate,
- shortness of breath,
- dizziness or lightheadedness,
- fatigue or lack of energy
• Not for use in children under 2 years of age.
• Keep out of reach of children.
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL - Carton
INGREDIENTS AND APPEARANCE
benzocaine spray, metered
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0699-3100 Route of Administration PERIODONTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 220 mg in 1 g Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) BENZALDEHYDE (UNII: TA269SD04T) APAFLURANE (UNII: R40P36GDK6) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0699-3100-02 1 in 1 CARTON 01/01/1900 1 57 g in 1 CANISTER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/1900 Labeler - Dentsply LLC. Professional Division Trading as "Sultan Healthcare" (167087753) Establishment Name Address ID/FEI Business Operations Sciarra Laboratories, Inc. 824900369 manufacture(0699-3100)