Label: ULTRACARE ANESTHETIC GEL- benzocaine gel
- NDC Code(s): 10129-072-01
- Packager: The Belport Company, Inc. DBA Gingi-Pak
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 20, 2024
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- Uses
- ADVERSE REACTIONS
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- DO NOT USE
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ASK DOCTOR/PHARMACIST
Ask doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharnx that might obtund protective reflexes. Stop use and ask doctor if sore throat is severe for more than 2 days, fever, headache, rash, nausea, or vomiting develops, mouth sore does not go away within 10 days, irritation, pain or redness worsens.
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DOSAGE & ADMINISTRATION
Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anethestic. Sterile cotton or gause should be used in applying anesthetic to mucosa. Care must be taken to avoid cross contamination between patients. Total dose should not exceed the amount required for anesthesia. Apply to the affected area. Remain in place for at least 1 minutes and then spit. Use up to 4 times daily or as directed by dentist or doctor. Do not exceed recommended dosage. This product is for adults and children 2 years or age and older. Children under 2 years of age should consult a dentist or a doctor.
- INACTIVE INGREDIENT
- WARNINGS
- SAFE HANDLING WARNING
- Oral Anesthetic
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTRACARE ANESTHETIC GEL
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10129-072 Route of Administration DENTAL, PERIODONTAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10129-072-01 30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/20/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 03/20/2024 Labeler - The Belport Company, Inc. DBA Gingi-Pak (008480121)