OTC Medication Information: Chloraseptic Warming Sore Throat

CHLORASEPTIC WARMING SORE THROAT- 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.

[ Chloraseptic © Warming Sore Throat Lozenges – Honey ]

Drug Facts

Active i ngredient

(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 i nformation

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

Inactive i ngredients

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]

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 i nformation

  • Store below 25º C
  • 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 Lozenges
Benzocaine Oral Anesthetic | Analgesic 
18 lozenges | Honey Lemon
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

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

Chloraseptic© Warming SORE THROAT
Benzocaine Oral Anesthetic | Analgesic Lozenges
18 lozenges | Green Tea with real honey
(click image for full-size original)
CHLORASEPTIC WARMING SORE THROAT
benzocaine lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-018
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 15 mg
Inactive Ingredients
Ingredient Name Strength
CORN SYRUP
EPIGALLOCATECHIN GALLATE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
HONEY
PROPYLENE GLYCOL
LECITHIN, SOYBEAN
SUCROSE
GLYCERIN
WATER
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 4mm
Flavor HONEY (Green Tea) Imprint Code C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67172-018-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 18 LOZENGE in 1 BLISTER PACK This package is contained within the CARTON (67172-018-02)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 15 mg
Inactive Ingredients
Ingredient Name Strength
CORN SYRUP
FD&C YELLOW NO. 5
GLYCERIN
HONEY
PROPYLENE GLYCOL
LECITHIN, SOYBEAN
SUCROSE
WATER
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 4mm
Flavor HONEY Imprint Code C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67172-017-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 18 LOZENGE in 1 BLISTER PACK This package is contained within the CARTON (67172-017-02)
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)

Revised: 11/2019 Prestige Brands Holdings, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2019. All Rights Reserved.