Drug Facts

Composition & Product

Active Ingredients

Phenol (1.5 g)

Inactive Ingredients

Fd&c Red No. 40 Glycerin Water Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-09-01

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 doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by doctor.

Directions

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.
Adults and children 6 years of age and older:For each application, spray 5 times.
Children under 12 years of ageshould be supervised in the use of this product.
Children under 3 years of age: Ask a doctor or dentist.

Active Ingredient

Phenol 1.4%

Other Information

Store at room temperature
Check expiration date before using.

Inactive Ingredients

FD&C Red # 40, flavor, glycerin, purified water, sucralose

Drug Facts (continued)

Keep out of the reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Principal Display Pane

COMPARE TO the active ingredient in CHLORASEPTIC ^®*

NDC 0904-6305-21

MAJOR ^®

Cherry flavor

Sore Throat Spray

Relieves Sore Throat Pain

New Sprayer

SUGAR- FREE

ASPIRIN-FREE

GLUTEN-FREE

Cherry Flavor

6 FL OZ (177 mL)

Tamper-Evident: Do not use i9f imprinted shrink band is broken or missing

Distributed By

MAJOR ^®PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

This product is not manufactured or distributed by Medtech Products Inc., a Prestige Brands Co., distributor of Chloraseptic ^®.

Questions Or Comments?

1-800-616-2471

When Using This Product

do not exceed recommended dosage.

If Pregnant Or Breast Feeding

ask a doctor before use.

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.

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 doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by doctor.

Directions

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.
Adults and children 6 years of age and older:For each application, spray 5 times.
Children under 12 years of ageshould be supervised in the use of this product.
Children under 3 years of age: Ask a doctor or dentist.

Active Ingredient

Phenol 1.4%

Other Information

Store at room temperature
Check expiration date before using.

Inactive Ingredients

FD&C Red # 40, flavor, glycerin, purified water, sucralose

Drug Facts (continued)

Keep out of the reach of children. In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Principal Display Pane

COMPARE TO the active ingredient in CHLORASEPTIC ^®*

NDC 0904-6305-21

MAJOR ^®

Cherry flavor

Sore Throat Spray

Relieves Sore Throat Pain

New Sprayer

SUGAR- FREE

ASPIRIN-FREE

GLUTEN-FREE

Cherry Flavor

6 FL OZ (177 mL)

Tamper-Evident: Do not use i9f imprinted shrink band is broken or missing

Distributed By

MAJOR ^®PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

This product is not manufactured or distributed by Medtech Products Inc., a Prestige Brands Co., distributor of Chloraseptic ^®.

Questions Or Comments? (Questions or comments?)

1-800-616-2471

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 doctor before use.

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

[{"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOL", "unii": "339NCG44TV", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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 doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by doctor.", "Directions": "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. Adults and children 6 years of age and older: For each application, spray 5 times. Children under 12 years of age should be supervised in the use of this product. Children under 3 years of age : Ask a doctor or dentist.", "Active Ingredient": "Phenol 1.4%", "Other Information": "Store at room temperature Check expiration date before using.", "Inactive Ingredients": "FD&C Red # 40, flavor, glycerin, purified water, sucralose", "Drug Facts (continued)": "Keep out of the reach of children. In case of overdose or accidental poisoning , get medical help or contact a Poison Control Center right away at 1-800-222-1222.", "Principal Display Pane": "COMPARE TO the active ingredient in CHLORASEPTIC ®* NDC 0904-6305-21 MAJOR ® Cherry flavor Sore Throat Spray Relieves Sore Throat Pain New Sprayer SUGAR- FREE ASPIRIN-FREE GLUTEN-FREE Cherry Flavor 6 FL OZ (177 mL) Tamper-Evident: Do not use i9f imprinted shrink band is broken or missing Distributed By MAJOR ® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 This product is not manufactured or distributed by Medtech Products Inc., a Prestige Brands Co., distributor of Chloraseptic ® .", "Questions or comments?": "1-800-616-2471", "When using this product": "do not exceed recommended dosage.", "If pregnant or breast-feeding": "ask a doctor before use.", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information