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.

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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 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.
  • Tamper Evident: Do not use if blister package with “Chloraseptic®” name has been disturbed or opened.

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

SOOTIHNG LIQUID CENTER
Pharmacist #1 Recommended
Chloraseptic warming SORE THROAT
Benzocaine Oral Anesthetic | Analgesic Lozenges
18 lozenges | Honey Lemon with real honey

PRINCIPAL DISPLAY PANEL SOOTIHNG LIQUID CENTER Pharmacist #1 Recommended Chloraseptic warming SORE THROAT Benzocaine Oral Anesthetic | Analgesic Lozenges 18 lozenges | Honey Lemon with real honey

CHLORASEPTIC WARMING SORE THROAT 
benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-017
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE15 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP 
LECITHIN, SOYBEAN 
SUCRALOSE 
WATER 
FD&C YELLOW NO. 5 
PROPYLENE GLYCOL 
HONEY 
GLYCERIN 
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize4mm
FlavorHONEYImprint Code C
Contains    
Packaging
#Item CodePackage Description
1NDC:67172-017-021 in 1 CARTON
118 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35601/01/2012
Labeler - Prestige Brands Holdings, Inc. (159655021)
Establishment
NameAddressID/FEIBusiness Operations
BestSweet, Inc.002149136MANUFACTURE

Revised: 02/2012
Document Id: 72f0f1a9-a653-46d1-9c8d-ffecceab2b46
Set id: 7c161a17-cf82-4de3-8348-888c040df0f9
Version: 1
Effective Time: 20120223
 
Prestige Brands Holdings, Inc.