SORE THROAT CHERRY- phenol spray 
P & L Development, LLC

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(s)

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

Use(s)

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 doctor if

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

If Pregnant or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

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's 12 years or older..............for each application, spray 5 times
children 3 years to 12 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 controlled room temperature

Inactive Ingredients

flavor, glycerin, purified water, red 40, saccharin sodium

Principal Display Panel


Aaron Brands

Phenol/Oral Anesthetic

Sore Throat Spray Cherry

Instant Acting

Relieves Sore Throat

Compare to Active Ingredient in Chloraseptic®

Alcohol Free, Aspirin Free, Sugar Free

6 FL OZ (177 mL)

image of label


SORE THROAT CHERRY 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-4406
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49580-4406-6177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/200912/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35608/01/200912/30/2020
Labeler - P & L Development, LLC (101896231)

Revised: 12/2019
 
P & L Development, LLC