Label: XESSO NEO- benzocaine spray
- NDC Code(s): 81777-106-04
- Packager: PREMIUM NATURAL COSMETICS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 14, 2024
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Warning Section
Warning
- METHEMOGLOBINEMIA WARNING: 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 the blood. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of
breath, dizziness or lightheadedness, fatigue, or lack of energy.
- Sore Throat Warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. For adult use only.
- Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.
- As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
- Stop use and consult a doctor if difficulty in breathing occurs, swelling or fever develops, or if sore mouth or throat symptoms do not improve within 7 days.
- Do not exceed the recommended dosage.
- Keep away from fire or flames.
- Directions
- Inactive Ingredients
- Use Section
- Active Ingredient
- Purpose
- Other Information
- PDP and Back Panel
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INGREDIENTS AND APPEARANCE
XESSO NEO
benzocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81777-106 Route of Administration TOPICAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) 0.1 g in 100 mL POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) 2 g in 100 mL SUCRALOSE (UNII: 96K6UQ3ZD4) 1 g in 100 mL FD&C RED NO. 40 (UNII: WZB9127XOA) 0.0006 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 33 g in 100 mL WATER (UNII: 059QF0KO0R) 18 g in 100 mL ALCOHOL 95% (UNII: 7528N5H79B) 40 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81777-106-04 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/16/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 04/16/2024 Labeler - PREMIUM NATURAL COSMETICS INC (051403646) Registrant - Creative Essences Inc (079120182) Establishment Name Address ID/FEI Business Operations Creative Essences Inc 079120182 manufacture(81777-106)