NICE SORE THROAT SPEARMINT- phenol spray

NICE SORE THROAT Spearmint by

Drug Labeling and Warnings

NICE SORE THROAT Spearmint by is a Otc medication manufactured, distributed, or labeled by Leosons Overseas Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient & Purposes

• Active Ingredients: Purposes
• 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

• apply to the affected area
• allow to remain in place for at least 15 seconds, then spit out
• use every 2 hours or as directed by a doctor or dentist

• age: dose
• adults and children 12 years of age and older: for 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 age: consult a doctor or dentist

Other Information

• store at room temperature

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)

INGREDIENTS AND APPEARANCE

NICE SORE THROAT SPEARMINT 
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69626-0048
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.4 g  in 177 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69626-0048-6	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/07/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/07/2014

Labeler - Leosons Overseas Corp (148605470)