SORE THROAT- phenol spray

Sore Throat by

Drug Labeling and Warnings

Sore Throat by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Phenol 1.4%

Purpose

 Oral Anesthetic/Analgesic

Uses

 temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.

When using this product,

do not use more than directed.

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away. 

Directions

• apply to affected area
• use every 2 hours
• allow to remain in place for at least 15 seconds, then spit out

• age: dose
• adults and children 12 years and over: for each application, spray 5 times
• children 3 to 11 years: should be supervised in use of this product for each application, spray 3 times
• children under 3 years: ask a doctor or dentist

Other information

• store at 20º-25ºC (68º-77ºF). Do not refrigerate.

Inactive ingredients

D&C green #5, D&C yellow #10, FD&C green #3, glycerin, methol, purified water, saccharin sodium 

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

Fast Relief

Sore Throat Spray

Phenol/Oral Anesthetic

• fast-acting, long-lasting relief of minor sore throat and mouth pain

Menthol flavor

Compare to Chloraseptic® active ingredient*

TAMPER EVIDENT: DO NOT USE IF IMPRINTED WRAP AROUND THE CAP IS BROKEN OR TORN.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

*This product is not manufactured or distributed by Prestige Brands, inc., owner of the registered trademark Chloraseptic®.

Product Label

TopCare Sore Throat Spray

INGREDIENTS AND APPEARANCE

SORE THROAT 
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-065
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-065-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/31/2014	12/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	10/31/2014	12/30/2020

Labeler - TOP CARE (Topco Associates LLC) (006935977)