Sore Throat

Sore Throat
SPL v1
SPL
SPL Set ID 2379e23a-72fe-4e94-9d7e-9b623c0db174
Route
NASAL
Published
Effective Date 2024-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (14 mg)
Inactive Ingredients
Fd&c Red No. 40 Glycerin Sodium Saccharin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-12

Description

Phenol 1.4%............. Oral Anesthetic/Analgesic

Purpose

Phenol 1.4%............. Oral Anesthetic/Analgesic


Medication Information

Purpose

Phenol 1.4%............. Oral Anesthetic/Analgesic

Description

Phenol 1.4%............. Oral Anesthetic/Analgesic

Uses
  • For temporary relief of occasional minor throat irritation, pain, sore mouth, sore throat.
Section 42229-5
  • Tamper Evident: Do not use if printed shrink band is broken or missing.
  • This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic.

Questions or comments?

call 866-200-8310 (Mon-Fri. 9 am-5 pm EST)

Distributed by C.D.M.A Inc.

Novi, MI 48375

www.qualitychoice.com

Question: 800-935-2362

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor or dentist if

  • sore throat 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 doctor before use.

Section 50567-7

Sore throat waring: Severe and 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.

Whan using this product do not exceed recommended dose. Do not use more than 2 days. Use only as directed. Use of this container by more

than one person may spread infection.

Section 55105-1

Sore Throat Relief

Warnings

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
  • Before using the first time, remove the protective neck band and dust cap from the tip. To spray hold bottle straight up and press the

    nozzle with index finger without tilting head. Fully depress pump all the way down with a firm, even stroke. Wipe nozzle dry.
Other Information
  • Store at room temperature
Inactive Ingredients

cherry flavor, FD&C Red #40, glycerin, purified water, sodium saccharin.

Principal Display Panel

NDC-83324- 031 -06

Active Ingredient                         purpose

Phenol 1.4%............. Oral Anesthetic/Analgesic


Structured Label Content

Uses
  • For temporary relief of occasional minor throat irritation, pain, sore mouth, sore throat.
Section 42229-5 (42229-5)
  • Tamper Evident: Do not use if printed shrink band is broken or missing.
  • This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic.

Questions or comments?

call 866-200-8310 (Mon-Fri. 9 am-5 pm EST)

Distributed by C.D.M.A Inc.

Novi, MI 48375

www.qualitychoice.com

Question: 800-935-2362

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor or dentist if

  • sore throat 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 doctor before use.

Section 50567-7 (50567-7)

Sore throat waring: Severe and 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.

Whan using this product do not exceed recommended dose. Do not use more than 2 days. Use only as directed. Use of this container by more

than one person may spread infection.

Section 55105-1 (55105-1)

Sore Throat Relief

Warnings

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
  • Before using the first time, remove the protective neck band and dust cap from the tip. To spray hold bottle straight up and press the

    nozzle with index finger without tilting head. Fully depress pump all the way down with a firm, even stroke. Wipe nozzle dry.
Other Information (Other information)
  • Store at room temperature
Inactive Ingredients (Inactive ingredients)

cherry flavor, FD&C Red #40, glycerin, purified water, sodium saccharin.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC-83324- 031 -06

Active Ingredient                         purpose (Active Ingredient                         Purpose)

Phenol 1.4%............. Oral Anesthetic/Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)