CHLORASEPTIC SORE THROAT CITRUS- phenol spray 
CHLORASEPTIC SORE THROAT CHERRY- phenol spray 
CHLORASEPTIC SORE THROAT MENTHOL- phenol spray 
Prestige Brands Holdings, 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.

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Chloraseptic Spray

Drug Facts

Active ingredient

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

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 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.

Directions

Adults and children 3 years of age and older:

Other information

Inactive ingredients

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

Questions?

1-800-552-7932 Chloraseptic.com

Drug Facts

Active ingredient

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

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 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.

Directions

Adults and children 3 years of age and older:

Other information

Inactive ingredients

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

Questions?

1-800-552-7932 Chloraseptic.com

Drug Facts

Active ingredient

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

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 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.

Directions

Adults and children 3 years of age and older:

Other information

Inactive ingredients

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

Questions?

1-800-552-7932 Chloraseptic.com

PRINCIPAL DISPLAY PANEL

Chloraseptic® 
Phenol/Oral Anesthetic 

CITRUS
6 FL OZ (177 mL)

Chloraseptic® 
Phenol/Oral Anesthetic 

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 
6 FL OZ (177 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:67172-112
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 g  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:67172-112-31177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/01/2010
CHLORASEPTIC SORE THROAT CHERRY 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 g  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:67172-111-31177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/01/2010
CHLORASEPTIC SORE THROAT MENTHOL 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-113
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 g  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:67172-113-31177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/01/2010
Labeler - Prestige Brands Holdings, Inc. (159655021)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208analysis(67172-112, 67172-111, 67172-113) , label(67172-112, 67172-111, 67172-113) , manufacture(67172-112, 67172-111, 67172-113) , pack(67172-112, 67172-111, 67172-113)

Revised: 6/2023
Document Id: f8688121-fa5d-4a4d-9add-371a73bb6dc4
Set id: d5d62f7a-8f92-4d42-a2fb-691f896f72fc
Version: 6
Effective Time: 20230602
 
Prestige Brands Holdings, Inc.