CHLORASEPTIC MAX- menthol and benzocaine lozenge

CHLORASEPTIC MAX by

Drug Labeling and Warnings

CHLORASEPTIC MAX 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

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

(in each lozenge)

Benzocaine 15 mg

Purpose

Oral Anesthetic/Analgesic

Active Ingredients

(in each lozenge)

Menthol 10 mg

Purpose

Oral Anesthetic/Analgesic 

Uses

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

Warnings

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

∙ pale, gray, or blue colored skin (cyanosis)

∙ headache

∙ rapid heart rate

∙ shortness of breath

∙ dizziness or lightheadedness

∙ fatigue or lack of energy

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.

If a skin reaction occurs, stop use and seek medical help right away.

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.

Do not use

∙ for teething

∙ in children under 6 years of age

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 (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: Do not use.

Other Information

• Store between 15○ - 30○C (59○ - 86○F)
  
• Protect from moisture.
  
• Check expiration date before using.

Inactive Ingredients

corn syrup, FD&C blue no. 1, FD&C red no. 40, glycerin, natural & artificial flavors, propylene glycol, soy lecithin, sucrose, water

Questions?

1-800-552-7932 Chloraseptic.com

PRINCIPAL DISPLAY PANEL

Chloraseptic® Max
SORE THROAT Lozenges
15 lozenges | Wild Berries

INGREDIENTS AND APPEARANCE

CHLORASEPTIC MAX 
menthol and benzocaine lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-114
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	RED	Score	2 pieces
Shape	OVAL	Size	4mm
Flavor	BERRY (Wild berries)	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67172-114-61	1 in 1 CARTON	08/01/2010
1		15 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	08/01/2010

Labeler - Prestige Brands Holdings, Inc. (159655021)