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 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHLORASEPTIC SORE THROAT MAX 
phenol and glycerin spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1749
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.5 mg  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	33 mg  in 100 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: 0295-1749-05	1 in 1 BOX	01/01/2017
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	01/01/2017

Labeler - Denison Pharmaceuticals, Inc. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	manufacture(0295-1749)