CHLORASEPTIC SORE THROAT LIQUID CENTER- menthol and benzocaine lozenge 
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 Cherry Honey Lemon and Citrus Lozenges

Drug Facts

Chloraseptic Cherry Lozenges

Active Ingredients

(in each lozenge)

Benzocaine 6 mg

Purpose

Oral Anesthetic/Analgesic

Active Ingredients

(in each lozenge)

Menthol 10 mg

Purpose

Oral Anesthetic/Analgesic

Uses

Temporarily relieves:

Warnings

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

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 administer to children under 6 years of age unless directed by a doctor.

When using this product:

do not exceed recommended dosage.

Stop use and ask a dentist or doctor 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

Other Information

Inactive Ingredients

Corn Syrup, FD&C Red #40, Flavor, Glycerine, Soy Lecithin, Sucrose, Water

Questions?

1-800-552-7932 or www.chloraseptic.com

Drug Facts

Chloraseptic Citrus Lozenges

Active Ingredients

(in each lozenge)

Benzocaine 6 mg

Purpose

Oral Anesthetic/Analgesic

Active Ingredients

(in each lozenge)

Menthol 10 mg

Purpose

Oral Anesthetic/Analgesic

Uses

Temporarily relieves:

Warnings

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

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 administer to children under 6 years of age unless directed by a doctor.

When using this product:

do not exceed recommended dosage.

Stop use and ask a dentist or doctor 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

Other Information

Inactive Ingredients

Corn Syrup, FD&C Red #40, FD&C Yellow #6, Flavor, Glycerine, Propylene Glycol, Soy Lecithin, Sucrose, Water

Questions?

1-800-552-7932 or www.chloraseptic.com

Drug Facts

Chloraseptic Honey Lemon Lozenges

Active Ingredients

(in each lozenge)

Benzocaine 6 mg

Purpose

Oral Anesthetic/Analgesic

Active Ingredients

(in each lozenge)

Menthol 10 mg

Purpose

Oral Anesthetic/Analgesic

Uses

Temporarily relieves:

Warnings

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

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 administer to children under 6 years of age unless directed by a doctor.

When using this product:

do not exceed recommended dosage.

Stop use and ask a dentist or doctor 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

Other Information

Inactive Ingredients

Corn Syrup, FD&C Yellow #5, Flavor, Glycerine, Honey, Propylene Glycol, Soy Lecithin, Sucrose, Water

Questions?

1-800-552-7932 or www.chloraseptic.com

PRINCIPAL DISPLAY PANEL

Chloraseptic® 
SORE THROAT
18 lozenges | Cherry

PRINCIPAL DISPLAY PANEL
Chloraseptic® 
SORE THROAT 
15 lozenges | Cherry

PRINCIPAL DISPLAY PANEL

Chloraseptic® 
SORE THROAT
18 lozenges | Citrus

PRINCIPAL DISPLAY PANEL
Chloraseptic® 
SORE THROAT 
18 lozenges | Citrus

PRINCIPAL DISPLAY PANEL

Chloraseptic® 
SORE THROAT
18 lozenges | Honey Lemon with real honey

PRINCIPAL DISPLAY PANEL
Chloraseptic® 
SORE THROAT 
18 lozenges | Honey Lemon with real honey

CHLORASEPTIC SORE THROAT LIQUID CENTER 
menthol and benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP (UNII: 9G5L16BK6N)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorREDScore2 pieces
ShapeOVALSize4mm
FlavorCHERRYImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67172-011-011 in 1 CARTON
118 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2010
CHLORASEPTIC SORE THROAT LIQUID CENTER 
menthol and benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP (UNII: 9G5L16BK6N)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorORANGEScore2 pieces
ShapeOVALSize4mm
FlavorCITRUSImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67172-012-011 in 1 CARTON
118 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2010
CHLORASEPTIC SORE THROAT LIQUID CENTER 
menthol and benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP (UNII: 9G5L16BK6N)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HONEY (UNII: Y9H1V576FH)  
Product Characteristics
ColorYELLOWScore2 pieces
ShapeOVALSize4mm
FlavorHONEYImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67172-013-011 in 1 CARTON
118 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2010
Labeler - Prestige Brands Holdings, Inc. (159655021)
Establishment
NameAddressID/FEIBusiness Operations
BestSweet, Inc.002149136MANUFACTURE

Revised: 11/2010
Document Id: a168aa95-402e-4476-ba95-f267d4d86684
Set id: dfb0c915-458e-4af5-8a33-38b768980c90
Version: 1
Effective Time: 20101119
 
Prestige Brands Holdings, Inc.