SORE THROAT MENTHOL- phenol spray 
Care One (American Sales Company)

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.

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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
  • irritation, 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 Poison Control Center (1-800-222-1222) right away.

Directions

  • apply to the affected area
  • use every 2 hours
  • allow to remain in place for at least 15 seconds, then spit out
agedose 
 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, menthol, purified water, saccharin sodium

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the Active Ingredient in Chloraseptic®*

FAST RELIEF

SORE THROAT SPRAY

PHENOL / ORAL ANESTHETIC

MENTHOL FLAVOR

Instant-Acting

Relieves Sore Throat

Alcohol Free

Aspirin Free

Sugar Free

FL OZ (mL)

*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Chloraseptic®.

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

DISTRIBUTED BY FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

Package Label

Phenol 1.4%

Care One Sore Throat Spray Menthol

 

SORE THROAT  MENTHOL
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-377
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
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorGREEN (clear) Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-377-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/201412/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35605/01/201412/31/2020
Labeler - Care One (American Sales Company) (809183973)

Revised: 10/2019
Document Id: d6b42df2-367b-451f-ae83-302b6d2f66d7
Set id: be097aef-eb1d-4ccd-8633-e6f21ce8707a
Version: 4
Effective Time: 20191030
 
Care One (American Sales Company)