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Sore Throat by TOP CARE (Topco Associates LLC)

Dosage form: spray
Ingredients: PHENOL 1.5g in 100mL
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-065

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.

Drug Facts

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

SORE THROAT 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-065
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (PHENOL) PHENOL1.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
SACCHARIN SODIUM 
FD&C GREEN NO. 3 
D&C GREEN NO. 5 
D&C YELLOW NO. 10 
MENTHOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-065-06177 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35610/31/2014
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 10/2017
 
TOP CARE (Topco Associates LLC)

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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