Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d
Route
ORAL
Published
Effective Date 2024-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (1.4 g)
Inactive Ingredients
Alcohol Fd&c Red No. 40 Glycerin Water Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-11-30

Description

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic


Medication Information

Purpose

Oral Anesthetic/Analgesic

Description

Phenol 1.4%

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 a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

Directions
  • adults and children 2 years of age and older
    • apply to affected area (one spray)
    • allow to remain in place for at least 15 seconds, then spit out 
    • use every 2 hours as directed by a doctor or dentist
  • children under 12 years of age should be supervised in the used in this product
  • children under 2 years of age, consult a doctor or dentist
Package Label
SIGNATURE SELECT Sore Throat Spray Cherry Flavor
Active Ingredient

Phenol 1.4%

Other Information
  • store between  20º-25ºC (68º-77ºF). Do not refrigerate.
Inactive Ingredients

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

Questions Or Comments?

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

Principal Display Panel

COMPARE TO Chloraseptic® Active Ingredient* 

SORE THROAT SPRAY

CHERRY FLAVOR

PHENOL 1.4 %

Oral Anesthetic / Analgesic

Relieves Sore Throat

Alcohol 0.10%

ASPIRIN FREE

SUGAR FREE

FL OZ (mL)

*This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic®.

TAMPER EVIDENT: Do not use if imprinted shrink band is broken or missing. For Lot and Expiration Date, see bottom of bottle. Keep capon when not in use.

DISTRIBUTED BY

BETTER LIVING BRAND LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

When Using This Product,

do not exceed recommended dose.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Stop Use and Ask A Dentist Or Doctor If
  • sore throat is severe, or lasts for more than 2 days
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • fever, headache, rash, swelling, nausea or vomiting develops

Structured Label Content

Uses

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

Purpose

Oral Anesthetic/Analgesic

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

Directions
  • adults and children 2 years of age and older
    • apply to affected area (one spray)
    • allow to remain in place for at least 15 seconds, then spit out 
    • use every 2 hours as directed by a doctor or dentist
  • children under 12 years of age should be supervised in the used in this product
  • children under 2 years of age, consult a doctor or dentist
Package Label
SIGNATURE SELECT Sore Throat Spray Cherry Flavor
Active Ingredient (Active ingredient)

Phenol 1.4%

Other Information (Other information)
  • store between  20º-25ºC (68º-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

COMPARE TO Chloraseptic® Active Ingredient* 

SORE THROAT SPRAY

CHERRY FLAVOR

PHENOL 1.4 %

Oral Anesthetic / Analgesic

Relieves Sore Throat

Alcohol 0.10%

ASPIRIN FREE

SUGAR FREE

FL OZ (mL)

*This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic®.

TAMPER EVIDENT: Do not use if imprinted shrink band is broken or missing. For Lot and Expiration Date, see bottom of bottle. Keep capon when not in use.

DISTRIBUTED BY

BETTER LIVING BRAND LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

When Using This Product, (When using this product,)

do not exceed recommended dose.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Ask A Dentist Or Doctor If (Stop use and ask a dentist or doctor if)
  • sore throat is severe, or lasts for more than 2 days
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • fever, headache, rash, swelling, nausea or vomiting develops

Advanced Ingredient Data


Raw Label Data

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