NICE SORE THROAT SPEARMINT- 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.

----------

NICE Sore Throat Spearmint

Drug Facts

Active Ingredient & 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

D&C green #5, D&C yellow #10, FD&C green #3, flavor, glycerin, propylene glycol, sodium saccharin, and water.

Questions?

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

Distributed by:

LEOSONS
Albany, New York 12205

Made in USA

Principal Display Panel

SUGAR FREE • ALCOHOL FREE • ASPIRIN FREE

N'ICE®

P H E N O L / O R A L A N E S T H E T I C

Sore Throat Spray

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

SPEARMINT FLAVOR

6 FL OZ (177 mL)

NICE Throat Spearmint

NICE SORE THROAT SPEARMINT 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69626-0048
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 g  in 177 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69626-0048-6177 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: b6fd9d0b-00f4-de3c-e053-2a95a90a1b0e
Set id: 5fc68f04-ec15-11c0-e053-2a91aa0a1952
Version: 2
Effective Time: 20201221
 
Leosons Overseas Corp