CHLORASEPTIC SORE THROAT MAX- phenol and glycerin spray

Chloraseptic Sore Throat Max by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Phenol 1.5%

Purpose

Oral Anesthetic/Analgesic

Active Ingredients

Glycerin 33%

Purpose

Demulcent

Uses

for the temporary relief of ■ occasional minor irritation, pain, sore mouth and sore throat ■ minor discomfort and protection of irritated areas in sore mouth and sore throat

Warnings

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.

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 older:

• apply to the affected area (one spray)
  
• allow to remain in place for at least 15 seconds, then spit out
  
• use every 2 hours or as directed by a doctor or dentist

Children under 12 years of age should be supervised by an adult in the use of this product.

Children under 3 years of age: consult a doctor or dentist.

Other Information

• store at room temperature
  
• check expiration date before using

Inactive ingredients

FD&C blue no. 1, FD&C red no. 40, flavor, purified water, sodium saccharin, sucralose

Questions?

1-800-552-7932 Chloraseptic.com

PRINCIPAL DISPLAY PANEL

Chloraseptic® Max Sore Throat

Phenol Oral Anesthetic /Demulcent Spray  1 fl oz (30 mL) | Wild Berries

INGREDIENTS AND APPEARANCE

CHLORASEPTIC SORE THROAT MAX 
phenol and glycerin spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-937
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	15 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	330 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67172-937-52	1 in 1 BOX	02/01/2011
1		30 mL in 1 BOTTLE, DISPENSING; 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	02/01/2011

Labeler - Prestige Brands Holdings, Inc. (159655021)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	MANUFACTURE(67172-937)