CARE ONE SORE THROAT- phenol spray 
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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American Sales Company Sore Throat Spray Drug Facts

Active ingredient

Phenol 1.4%

Purpose

Oral anesthetic/analgesic

Uses

For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. 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 or dentist if

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Adults and children 3 years of age and older:

apply to the affected area (one spray)
allow to remain in place for at least 15 seconds, then spit out
use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of this product.

Children under 3 years of age: consult a doctor or dentist

Other information

store at 20-25oC (68-77oF)

Inactive ingredients

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

Principal Display Panel

Compare to the Active Ingredient in Chloraseptic®

FAST RELIEF

SORE THROAT SPRAY

PHENOL / ORAL ANESTHETIC

CHERRY FLAVOR

Instant-Acting

Relieves Sore Throat

See New Directions

Sore Throat Spray Label Image
CARE ONE SORE THROAT 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-328
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorRED (clear) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-328-30177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/19/200312/06/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/19/200312/06/2016
Labeler - American Sales Company (809183973)

Revised: 11/2017
 
American Sales Company