drug facts

drug facts
SPL v7
SPL
SPL Set ID 9128d59c-6fa9-4358-865a-802257a9bd25
Route
oral
Published
Effective Date 2025-12-16
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

Pill Appearance
Color: red
Marketing Status
otc monograph drug completed Since 2014-07-31 Until 2027-01-31

Purpose

Oral Anesthetic/Analgesic

Description

Phenol 1.4%


Medication Information

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a  doctor promptly. Do not use more than 2 days.

Uses

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

Purpose

Oral Anesthetic/Analgesic

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 use of this product
  • children under 6 years of age, consult a doctor or dentist
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

Description

Phenol 1.4%

Principal Display Panel

Compare to Chloraseptic® active ingredient*

Sore Throat Spray

Phenol 1.4%

Oral Anesthetic / Analgesic Spray

Relieves sore throat

  • Aspirin free
  • Sugar Free

For ages 2 years and older

Cherry Flavor

0.10% ALCOHOL

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 IN USE

Distributed by:

Walmart Inc.,

Bentonville, AR 72716

Package Label
EQUATE Sore Throat Spray Cherry Flavor
Active Ingredient

Phenol 1.4%

Questions Or Comments?

Call 1-888-287-1915

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 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

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a  doctor promptly. Do not use more than 2 days.

Uses

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

Purpose

Oral Anesthetic/Analgesic

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 use of this product
  • children under 6 years of age, consult a doctor or dentist
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 Chloraseptic® active ingredient*

Sore Throat Spray

Phenol 1.4%

Oral Anesthetic / Analgesic Spray

Relieves sore throat

  • Aspirin free
  • Sugar Free

For ages 2 years and older

Cherry Flavor

0.10% ALCOHOL

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 IN USE

Distributed by:

Walmart Inc.,

Bentonville, AR 72716

Package Label
EQUATE Sore Throat Spray Cherry Flavor
Active Ingredient (Active ingredient)

Phenol 1.4%

Questions Or Comments? (Questions or comments?)

Call 1-888-287-1915

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 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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