Label: ULTRACARE ANESTHETIC GEL- benzocaine gel
- NDC Code(s): 10129-071-01
- Packager: The Bellport Company, Inc. dba Gingi-Pak
- 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.
Drug Label Information
Updated February 8, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
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Warnings
For external use only.
Stop use and ask a doctor if
- Sore throat is severe and 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
Ask a doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes.
Methemoglobinemia warning
Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated prompltly because it reduces the amount of oxygen carried in blood. Cease use and seek immediate medical attention if one of the following symptoms develops: -Pale, gray, or blue colored skin (cyanosis) - Headache - Rapid heart rate - Shortness of breath _ Dizziness or lightheadedness - Fatigue or lack of energy
- Purpose
- Uses
- Indications
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Dosage and Administration
Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anesthetic. Sterile cotton or gauze should be used in applying anesthetic to mucosa. Care must be taken to avoid cross-contamination between patients. Total dose should not exceed the amout required for anethesia.
- Apply to the affected area.
- Remain in place for at least 1 minute and then spit.
- Use up to 4 times daily or as directed by a dentist or doctor.
- Do not exceed recommended dosage.
- This product is for adultsand children 2 years of age and older.
- Chidlren under 2 years of age should consult a dentist or a doctor.
- Other information
- 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:10129-071 Route of Administration DENTAL, TOPICAL, PERIODONTAL 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 400 (UNII: B697894SGQ) POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) Product Characteristics Color Score Shape Size Flavor BERRY (walterberry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10129-071-01 30 g in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M022 02/08/2023 Labeler - The Bellport Company, Inc. dba Gingi-Pak (008480121) Registrant - Jeff Nichols (008480121) Establishment Name Address ID/FEI Business Operations The Bellport Company, Inc. dba Gingi-Pak 008480121 manufacture(10129-071)
