CHLORASEPTIC WARMING SORE THROAT- benzocaine lozenge

Chloraseptic Warming Sore Throat by

Drug Labeling and Warnings

Chloraseptic Warming Sore Throat by is a Otc medication manufactured, distributed, or labeled by Prestige Brands Holdings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

[Chloraseptic© Warming Sore Throat Lozenges – Honey ]

Drug Facts

Active ingredient

(in each lozenge)

Benzocaine 15 mg

Purpose

Oral Anesthetic/Analgesic

Uses

Temporarily relieves: occasional minor irritation, pain, sore throat and sore mouth

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 3 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 doctor 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 over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
  
• Children under 3 years of age: Consult a doctor or dentist.

Other information

• Store between 59ºF and 86ºF (15ºC - 30ºC).
  
• Protect from moisture.
  
• Check expiration date before using.
  
• Contains FD&C yellow no. 5 (tartrazine) as a color additive.

Inactive ingredients

corn syrup, FD&C yellow no. 5, flavor, glycerin, honey, propylene glycol, soy lecithin, sucrose, water

Questions?

1-800-552-7932 Chloraseptic.com

[Chloraseptic Green Tea with Real Honey]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

(in each lozenge)

Benzocaine 15 mg

Purpose

Oral Anesthetic/Analgesic

Uses

Temporarily relieves:

• occasional minor irritation, pain, sore throat and sore mouth

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 3 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 doctor before use.

Keep out of reach of children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• Adults and children 6 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
  
• Children under 6 years of age: Consult a doctor or dentist.

Other information

• Store below 25ºC  
  
• Protect from moisture.

Inactive Ingredients

Corn Syrup, Epigallocatechin Gallate (EGCG), FD&C Blue #1, FD&C Yellow #5, Flavor, Honey, Propylene Glycol, Soy Lecithin, Sucrose, Glycerin, Water

Questions?

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

PRINCIPAL DISPLAY PANEL

Chloraseptic© Warming Sore Throat Lozenges
Benzocaine Oral Anesthetic | Analgesic
18 lozenges | Honey Lemon

PRINCIPAL DISPLAY PANEL

Chloraseptic© Warming SORE THROAT
Benzocaine Oral Anesthetic | Analgesic Lozenges
18 lozenges | Green Tea with real honey

INGREDIENTS AND APPEARANCE

CHLORASEPTIC WARMING SORE THROAT 
benzocaine lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-018
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
HONEY (UNII: Y9H1V576FH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	4mm
Flavor	HONEY (Green Tea)	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67172-018-02	1 in 1 CARTON	09/01/2012
1		18 in 1 BLISTER PACK; 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	09/01/2012

CHLORASEPTIC WARMING SORE THROAT 
benzocaine lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-017
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
HONEY (UNII: Y9H1V576FH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL	Size	4mm
Flavor	HONEY	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67172-017-02	1 in 1 CARTON	01/01/2012
1		18 in 1 BLISTER PACK; 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	01/01/2012

Labeler - Prestige Brands Holdings, Inc. (159655021)