Your browser does not support JavaScript! CARE ONE SORE THROAT (PHENOL) SPRAY [AMERICAN SALES COMPANY]
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CARE ONE SORE THROAT (phenol) spray
[American Sales Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (PHENOL) PHENOL1.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
GLYCERIN 
WATER 
SACCHARIN SODIUM 
Product Characteristics
ColorRED (clear) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-328-30177 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/19/2003
Labeler - American Sales Company (809183973)

Revised: 11/2012
Document Id: 3d6e2960-5484-4323-9498-a8456378c059
Set id: 502fd078-806f-4121-b507-da169b714fe2
Version: 2
Effective Time: 20121106
 
American Sales Company

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