Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 2fb3d17e-8ca3-4edb-8b82-4b484f42616e
Route
ORAL
Published
Effective Date 2025-12-03
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.

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, than 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


Package Label
Ready In Case - Sore Throat Spray Phenol 1.4%
Active Ingredient

Phenol 1.4%

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

alcohol, FD&C red no. 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 active ingredient in Chloraseptic®*

Sore Throat Spray

Phenol 1.4%

Oral anesthetic/analgesic

  • alcohol 0.10%
  • aspirin free
  • sugar free

Cherry flavor

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 WRAP BAND IS BROKEN OR MISSING. FOR LOT AND EXPIRATION DATE, SEE BOTTOM OF BOTTLE. KEEP CAP ON WHEN NOT IN USE.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

When Using This Product,

do not exceed recommended dose.

Stop Use and Ask A 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
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.


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.

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, than 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


Package Label
Ready In Case - Sore Throat Spray Phenol 1.4%
Active Ingredient (Active ingredient)

Phenol 1.4%

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

alcohol, FD&C red no. 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 active ingredient in Chloraseptic®*

Sore Throat Spray

Phenol 1.4%

Oral anesthetic/analgesic

  • alcohol 0.10%
  • aspirin free
  • sugar free

Cherry flavor

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 WRAP BAND IS BROKEN OR MISSING. FOR LOT AND EXPIRATION DATE, SEE BOTTOM OF BOTTLE. KEEP CAP ON WHEN NOT IN USE.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

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

do not exceed recommended dose.

Stop Use and Ask A Doctor If (Stop use and ask a 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
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.


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Raw Label Data

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