NICE SORE THROAT CHERRY- phenol spray 
Leosons Overseas Corp

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.

----------

N'ICE® Sore Throat Cherry

Drug Facts

Active Ingredients & Purposes

Active IngredientsPurposes
Phenol 1.4%Oral Anesthetic/ Analgesic

Uses

For temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

When using this product do not use more than directed.

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops
  • difficulty in breathing occurs

If pregnant or breast feeding,

  • ask a health professional before use.

Keep this and all drugs out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

agedose
adults and children 12 years of age and olderfor each application, spray 5 times
children 3 to under 12 years

should be supervised in use of this product;

for each application, spray 3 times

children under 3 years of ageconsult a doctor or dentist

Other Information

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.

Inactive Ingredients

citric acid, FD&C red #40, flavor, glycerin, propylene glycol, sodium citrate, sodium saccharin, and water.

Questions?

1-855-452-9500 or email at info@leosonsintl.com

Distributed by:

LEOSONS
Albany, New York 12205

MADE IN THE USA

Principal Display Panel

N'ICE®

PHENOL/ ORAL ANESTHETIC

Sore Throat Spray

Fast acting, long lasting relief of minor sore throat and mouth pain

Cherry Flavor

6 FL OZ (177 mL)

NICE Throat Cherry

NICE SORE THROAT CHERRY 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69626-0047
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69626-0047-6177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/07/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/07/2014
Labeler - Leosons Overseas Corp (148605470)

Revised: 12/2020
Document Id: b6fe3fff-1bd7-122c-e053-2995a90a7a6f
Set id: 5f21694c-d1c9-0e64-e053-2a91aa0a0ff0
Version: 3
Effective Time: 20201221
 
Leosons Overseas Corp