XESSO NEO- benzocaine spray 
PREMIUM NATURAL COSMETICS INC

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Xesso Neo 5% Benzocaine Oral Spray

Warning Section

Warning

breath, dizziness or lightheadedness, fatigue, or lack of energy.

Keep out of reach of children section

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.

Directions

Apply to the affected area (one spray).
Allow to remain in place for at least 15 seconds then spit out.
May be repeated every two hours as needed or as directed by a health care professional.

Inactive Ingredients

Alcohol, FD&C RED NO. 40, Glycerinm, Natural Flavors, PEG-40 Hydrogenated Castor Oil, Polyvinylpryyolidone (PVP), Sucralose), Water

Use Section

For temporary relief of minor throat irritation, pain, and sore throat.

Active Ingredient

Benzocaine 5%

Purpose

Oral Anesthetic

Other Information

Tamper-Evident: Do not use if tamper evident seal on the outside of the container is broken or missing.
Store at room temperature 20 - 25 C (68 - 77 F)

PDP and Back Panel

PDP

XESSO NEO 
benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81777-106
Route of AdministrationTOPICAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
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
FD&C RED NO. 40 (UNII: WZB9127XOA) 0.0006 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81777-106-0459 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/16/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01304/16/2024
Labeler - PREMIUM NATURAL COSMETICS INC (051403646)
Registrant - Creative Essences Inc (079120182)
Establishment
NameAddressID/FEIBusiness Operations
Creative Essences Inc079120182manufacture(81777-106)

Revised: 4/2024
Document Id: 163f32cd-4e52-950a-e063-6394a90a4816
Set id: 163f32cd-4e51-950a-e063-6394a90a4816
Version: 1
Effective Time: 20240416
 
PREMIUM NATURAL COSMETICS INC