SORE THROAT CHERRY- phenol spray 
Cardinal Health (Leader) 49781

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 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

alcohol, FD&C red #40, glycerin, natural & artificial flavor, purified water, saccharin sodium

Questions or comments?

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

Principal Display Panel

Compare to Chloraseptic® active ingredient*

Cherry Flavor

Sore Throat Spray

Phenol/Oral Anesthetic

Instant Acting/Relieves Sore Throat

Relief of Minor Sore Throat and Mouth Irritation

Alcohol 0.10%

FL OZ (mL)

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

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

DISTRIBUTED BY: CARDINAL HEALTH DUBLIN, OHIO 43017

CIN 4957643

www.myleader.com

1-800-200-6313

Package Label

Phenol 1.4%

Leader Sore Throat Spray

SORE THROAT  CHERRY
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-098
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
ALCOHOL (UNII: 3K9958V90M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-098-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/201412/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/31/201412/31/2020
Labeler - Cardinal Health (Leader) 49781 (097537435)

Revised: 11/2019
Document Id: 1c3acaa7-d0cc-481b-98c2-0c9addf9a3dc
Set id: 6364df2d-c37b-4d5d-91f4-26eddce185b4
Version: 3
Effective Time: 20191106
 
Cardinal Health (Leader) 49781