Chloraseptic Sore Throat Cherry Spray
FDA Label NDC 67172-111

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prestige Brands Holdings, Inc. for the product Chloraseptic Sore Throat Cherry (NDC 67172-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor or dentist if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Phenol 1.4%

Phenol 1.4%

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

Oral Anesthetic/Analgesic

Oral Anesthetic/Analgesic

Uses

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

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

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

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

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

When Using This Product

do not exceed recommended dosage.

do not exceed recommended dosage.

do not exceed recommended dosage.

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
    • sore mouth symptoms do not improve in 7 days
    • irritation, pain or redness persists or worsens
    • swelling, rash or fever develops
      • sore mouth symptoms do not improve in 7 days
      • irritation, pain or redness persists or worsens
      • swelling, rash or fever develops

If Pregnant Or Breast-Feeding,

ask a health care professional before use.

ask a health care professional before use.

ask a health care professional before use.

Keep Out Of Reach Of Children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

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.

    • 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.

      • 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.

Other Information

  • store at room temperature
  • check expiration date before using.
    • store at room temperature
    • check expiration date before using.
      • store at room temperature
      • 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

FD&C red no. 40, flavors, glycerin, purified water, sodium chloride, sodium citrate, sodium saccharin, sucralose

D&C green no. 5, D&C yellow no. 10, FD&C green no. 3, flavor, glycerin, purified water, sodium saccharin, sucralose

Questions?

1-800-552-7932 Chloraseptic.com

Drug Facts

1-800-552-7932 Chloraseptic.com

Drug Facts

1-800-552-7932 Chloraseptic.com

Principal Display Panel

Chloraseptic® Phenol/Oral Anesthetic 

SOOTHING CITRUS| 6 FL OZ (177 mL)

Chloraseptic® Phenol/oral Anesthetic Soothing Citrus| 6 Fl Oz (177 mL) (Chloraseptic Spray 01)

Chloraseptic® Phenol/oral Anesthetic Soothing Citrus| 6 Fl Oz (177 mL) (Chloraseptic Spray 01)

Chloraseptic® Phenol/Oral Anesthetic 

CHERRY Flavor

6 FL OZ (177 mL)

Chloraseptic® Phenol/oral Anesthetic Cherry Flavor 6 Fl Oz (177 mL) (Chloraseptic Spray 02)

Chloraseptic® Phenol/oral Anesthetic Cherry Flavor 6 Fl Oz (177 mL) (Chloraseptic Spray 02)

Chloraseptic® Phenol/Oral Anesthetic 

MENTHOL Flavor| 6 FL OZ (177 mL)

Chloraseptic® Phenol/oral Anesthetic Menthol Flavor| 6 Fl Oz (177 mL) (Chloraseptic Spray 03)

Chloraseptic® Phenol/oral Anesthetic Menthol Flavor| 6 Fl Oz (177 mL) (Chloraseptic Spray 03)

Chloraseptic® Phenol/Oral Anesthetic

CHERRY Flavor

0.67 FL OZ (20 mL)

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