Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 0f4dae93-2e42-4815-be2f-ff4887a8fd5f
Route
ORAL
Published
Effective Date 2024-11-20
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 2014-12-31

Description

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic


Medication Information

Purpose

Oral Anesthetic/Analgesic

Description

Phenol 1.4%

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 accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days.

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 or as directed by a dentist or doctor
  • children under 12 years of age should be supervised in the use of this product
  • children under 2 years of age: consult a dentist or doctor
Questions?

Call 800-824-1706 Monday-Friday 9am-4pm MST

Package Label
WINCO FOODS Sore Throat Relief 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

Principal Display Panel

*Compare to the active ingredient in Chloraseptic®

INSTANT ACTING

Sore Throat Relief

PHENOL 1.4%/ORAL ANESTHETIC/ANALGESIC

Alcohol 0.10%

Relieves Sore Throat Pain

Cherry Flavor

ARTIFICALLY FLAVORED

FL OZ (mL)

*This product is not manufactured or distributed by PRESTIGE CONSUMER HEALTHCARE, 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 cap on when not is use.

DISTRIBUTED BY:

WINCO FOODS LLC

BOISE, ID 83704

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 is 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 last for more than 2 days
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsen
  • fever, headache, rash, swelling, nausea or vomiting develops

Structured Label Content

Uses

temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation

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.

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 or as directed by a dentist or doctor
  • children under 12 years of age should be supervised in the use of this product
  • children under 2 years of age: consult a dentist or doctor
Questions?

Call 800-824-1706 Monday-Friday 9am-4pm MST

Package Label
WINCO FOODS Sore Throat Relief 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

Principal Display Panel

*Compare to the active ingredient in Chloraseptic®

INSTANT ACTING

Sore Throat Relief

PHENOL 1.4%/ORAL ANESTHETIC/ANALGESIC

Alcohol 0.10%

Relieves Sore Throat Pain

Cherry Flavor

ARTIFICALLY FLAVORED

FL OZ (mL)

*This product is not manufactured or distributed by PRESTIGE CONSUMER HEALTHCARE, 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 cap on when not is use.

DISTRIBUTED BY:

WINCO FOODS LLC

BOISE, ID 83704

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 is 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 last for more than 2 days
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsen
  • fever, headache, rash, swelling, nausea or vomiting develops

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)