Chloraseptic Spray

Chloraseptic Spray
SPL v11
SPL
SPL Set ID d5d62f7a-8f92-4d42-a2fb-691f896f72fc
Route
ORAL
Published
Effective Date 2025-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (1.4 g)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Fd&c Yellow No. 6 Glycerin Water Saccharin Sodium Sodium Citrate Sodium Chloride Sucralose D&c Green No. 5 D&c Yellow No. 10 Fd&c Green No. 3

Identifiers & Packaging

Pill Appearance
Color: orange Color: red Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-09-01

Description

Drug Facts

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50567-7

do not exceed recommended dosage.

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 give to children under 3 years of age unless directed by a doctor.

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.
Questions?

1-800-552-7932 Chloraseptic.com

Drug Facts

Active Ingredient

Phenol 1.4%

Other Information
  • store between 20-25°C (68-77 °F). Do not refrigerate.

  • Check expiration date before using.
Inactive Ingredients

Citric acid, FD&C Red #40, FD&C Yellow #6, flavor, glycerin, purified water, sodium saccharin, sodium citrate

Principal Display Panel

Chloraseptic® 

Phenol/Oral Anesthetic 



CITRUS

6 FL OZ (177 mL)

When Using This Product

do not exceed recommended dosage.

If Pregnant Or Breast Feeding,

ask a health care 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 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

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50567-7 (50567-7)

do not exceed recommended dosage.

Purpose

Oral pain reliever

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 give to children under 3 years of age unless directed by a doctor.

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.
Questions?

1-800-552-7932 Chloraseptic.com

Drug Facts

Active Ingredient (Active ingredient)

Phenol 1.4%

Other Information (Other information)
  • store between 20-25°C (68-77 °F). Do not refrigerate.

  • Check expiration date before using.
Inactive Ingredients (Inactive ingredients)

Citric acid, FD&C Red #40, FD&C Yellow #6, flavor, glycerin, purified water, sodium saccharin, sodium citrate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Chloraseptic® 

Phenol/Oral Anesthetic 



CITRUS

6 FL OZ (177 mL)

When Using This Product (When using this product)

do not exceed recommended dosage.

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

ask a health care 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 Doctor Or Dentist If (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

Advanced Ingredient Data


Raw Label Data

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