Chloraseptic Sore Throat Cherry — v11

Chloraseptic Sore Throat Cherry

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Version

v11

Effective date

September 26, 2025

Original packager

Yes

Sections captured

15

Identifiers

Document ID
7013a023-7366-4c7a-b25b-c76942be98a5
Set ID
d5d62f7a-8f92-4d42-a2fb-691f896f72fc
Application numbers
M022
Product NDCs
67172-111, 67172-112, 67172-113
Package NDCs
67172-111-31, 67172-112-31, 67172-113-31
Original packager NDCs
—

Names & Manufacturers

Brand names
Chloraseptic Sore Throat Cherry
Generic names
PHENOL
Manufacturer names
Prestige Brands Holdings, Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
PHENOL
Routes
ORAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
1101850, 616480
UNII
339NCG44TV
UPC
—

Structured Label Sections

Active Ingredient (3)

Sequence 1

Active ingredient Phenol 1.4%

Sequence 2

Active ingredient Phenol 1.4%

Sequence 3

Active ingredient Phenol 1.4%
Ask Doctor (3)

Sequence 1

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

Sequence 2

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 fever, headache, swelling, rash, nausea or vomiting develops

Sequence 3

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
Dosage And Administration (3)

Sequence 1

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.

Sequence 2

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.

Sequence 3

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.
Inactive Ingredient (3)

Sequence 1

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

Sequence 2

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

Sequence 3

Inactive ingredients D&C green no. 5, D&C yellow no. 10, FD&C green no. 3, flavor, glycerin, purified water, sodium saccharin, sucralose
Indications And Usage (3)

Sequence 1

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

Sequence 2

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

Sequence 3

Uses for the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.
Keep Out Of Reach Of Children (3)

Sequence 1

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.

Sequence 2

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.

Sequence 3

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.
Other Safety Information (3)

Sequence 1

Other information store between 20-25°C (68-77 °F). Do not refrigerate. Check expiration date before using.

Sequence 2

Other information store between 20-25°C (68-77 °F). Do not refrigerate. check expiration date before using.

Sequence 3

Other information store between 20-25°C (68-77 °F). Do not refrigerate. check expiration date before using
Package Label Principal Display Panel (3)

Sequence 1

PRINCIPAL DISPLAY PANEL Chloraseptic ® Phenol/Oral Anesthetic CITRUS 6 FL OZ (177 mL) Chloraseptic® Phenol/Oral Anesthetic CITRUS 6 FL OZ (177 mL)

Sequence 2

PRINCIPAL DISPLAY PANEL Chloraseptic ® Phenol/Oral Anesthetic CHERRY Flavor 6 FL OZ (177 mL) Chloraseptic® Phenol/Oral Anesthetic CHERRY Flavor 6 FL OZ (177 mL)

Sequence 3

PRINCIPAL DISPLAY PANEL Chloraseptic ® Phenol/Oral Anesthetic MENTHOL Flavor| 6 FL OZ (177 mL) Chloraseptic® Phenol/Oral Anesthetic MENTHOL Flavor| 6 FL OZ (177 mL)
Pregnancy Or Breast Feeding (3)

Sequence 1

If pregnant or breast-feeding, ask a health care professional before use.

Sequence 2

If pregnant or breast-feeding, ask a health care professional before use.

Sequence 3

If pregnant or breast-feeding, ask a health care professional before use.
Purpose (3)

Sequence 1

Purpose Oral pain reliever

Sequence 2

Purpose Oral pain reliever

Sequence 3

Purpose Oral pain reliever
Questions (3)

Sequence 1

Questions? 1-800-552-7932 Chloraseptic.com Drug Facts

Sequence 2

Questions? 1-800-552-7932 Chloraseptic.com Drug Facts

Sequence 3

Questions? 1-800-552-7932 Chloraseptic.com
Spl Product Data Elements (1)

Sequence 1

Chloraseptic Sore Throat Citrus Phenol PHENOL PHENOL CITRIC ACID MONOHYDRATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN WATER SACCHARIN SODIUM SODIUM CITRATE Chloraseptic Sore Throat Cherry Phenol PHENOL PHENOL FD&C RED NO. 40 GLYCERIN WATER SODIUM CHLORIDE SODIUM CITRATE SACCHARIN SODIUM SUCRALOSE Chloraseptic Sore Throat Menthol Phenol PHENOL PHENOL D&C GREEN NO. 5 D&C YELLOW NO. 10 FD&C GREEN NO. 3 GLYCERIN WATER SACCHARIN SODIUM SUCRALOSE
Spl Unclassified Section (1)

Sequence 1

Drug Facts
Warnings (3)

Sequence 1

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. When using this product 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 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.

Sequence 2

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. When using this product 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 fever, headache, swelling, rash, nausea or vomiting develops 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.

Sequence 3

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. When using this product 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 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.
When Using (3)

Sequence 1

When using this product do not exceed recommended dosage.

Sequence 2

When using this product do not exceed recommended dosage.

Sequence 3

When using this product do not exceed recommended dosage.

OpenFDA raw payload

{'application_number': ['M022'],
 'brand_name': ['Chloraseptic Sore Throat Cherry'],
 'generic_name': ['PHENOL'],
 'is_original_packager': [True],
 'manufacturer_name': ['Prestige Brands Holdings, Inc.'],
 'package_ndc': ['67172-112-31', '67172-111-31', '67172-113-31'],
 'product_ndc': ['67172-111', '67172-112', '67172-113'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['616480', '1101850'],
 'spl_id': ['7013a023-7366-4c7a-b25b-c76942be98a5'],
 'spl_set_id': ['d5d62f7a-8f92-4d42-a2fb-691f896f72fc'],
 'substance_name': ['PHENOL'],
 'unii': ['339NCG44TV']}