CHLORASEPTIC SORE THROAT CITRUS- phenol spray 
CHLORASEPTIC SORE THROAT CHERRY- phenol spray 
CHLORASEPTIC SORE THROAT MENTHOL- phenol spray 
Denison Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Chloraseptic Spray

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)

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)

Chloraseptic® Phenol/Oral Anesthetic CHERRY Flavor .67 FL OZ (20 mL)

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)

CHLORASEPTIC SORE THROAT CITRUS 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1588
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColororangeScore    
ShapeSize
FlavorCITRUSImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-1588-23177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/2017
CHLORASEPTIC SORE THROAT CHERRY 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9513
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-9513-23177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2017
2NDC:0295-9513-031 in 1 CARTON01/01/2017
220 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/2017
CHLORASEPTIC SORE THROAT MENTHOL 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1046
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorgreenScore    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-1046-23177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/2017
Labeler - Denison Pharmaceuticals, Inc. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, Inc.001207208manufacture(0295-1588, 0295-9513, 0295-1046)

Revised: 12/2018
 
Denison Pharmaceuticals, Inc.