CHLORASEPTIC SORE THROAT CITRUS- phenol spray CHLORASEPTIC SORE THROAT CHERRY- phenol spray CHLORASEPTIC SORE THROAT MENTHOL- phenol spray

Chloraseptic Sore Throat Menthol by

Drug Labeling and Warnings

Chloraseptic Sore Throat Menthol by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Chloraseptic Citrus Active ingredient

Phenol 1.4%

Chloraseptic Citrus Purpose

Oral Anesthetic/Analgesic

Chloraseptic Citrus Uses

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

Chloraseptic Citrus 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.

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.

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

Chloraseptic Citrus 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.

Chlorseptic Citrus Other information

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

Chloraseptic Citrus Inactive ingredients

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

Chloraseptic Citrus Questions?

1-800-552-7932 Chloraseptic.com

Drug Facts

Chloraseptic Cherry Active ingredient

Phenol 1.4%

Chloraseptic Cherry Purpose

Oral Anesthetic/Analgesic

Chloraseptic Cherry Uses

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

Chloraseptic Cherry 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.

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.

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

Chloraseptic Cherry 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.

Chloraseptic Cherry Other information

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

Chloraseptic Cherry Inactive ingredients

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

Chloraseptic Cherry Questions?

1-800-552-7932 Chloraseptic.com

Drug Facts

Chlorseptic Menthol Active ingredient

Phenol 1.4%

Chloraseptic Menthol Purpose

Oral Anesthetic/Analgesic

Chloraseptic Menthol Uses

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

Chloraseptic Menthol 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.

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.

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

Chloraseptic Menthol 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.

Chloraseptic Menthol Other information

• store at room temperature
  
• check expiration date before using

Chloraseptic Menthol Inactive ingredients

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

Chloraseptic Menthol Questions?

1-800-552-7932 Chloraseptic.com

PRINCIPAL DISPLAY PANEL

Chloraseptic ® Phenol/Oral Anesthetic



SOOTHING CITRUS| 6 FL OZ (177 mL)

PRINCIPAL DISPLAY PANEL

Chloraseptic ® Phenol/Oral Anesthetic



CHERRY Flavor

6 FL OZ (177 mL)

PRINCIPAL DISPLAY PANEL

Chloraseptic ® Phenol/Oral Anesthetic



MENTHOL Flavor| 6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

CHLORASEPTIC SORE THROAT CITRUS 
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1588
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.4 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	CITRUS	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1588-23	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2017

CHLORASEPTIC SORE THROAT CHERRY 
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9513
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.4 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9513-23	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2017
2	NDC: 0295-9513-03	1 in 1 CARTON	01/01/2017
2		20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2017

CHLORASEPTIC SORE THROAT MENTHOL 
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1046
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.4 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1046-23	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2017

Labeler - Denison Pharmaceuticals, Inc. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	manufacture(0295-1588, 0295-9513, 0295-1046)