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Chloraseptic Sore Throat Max by Denison Pharmaceuticals, Inc.

Medically reviewed on May 3, 2017

Dosage form: spray
Ingredients: PHENOL 1.5mg in 100mL, GLYCERIN 33mg in 100mL
Labeler: Denison Pharmaceuticals, Inc.
NDC Code: 0295-1749

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 Sore Throat Spray Max

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


Chloraseptic® Max Sore Throat

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

CHLORASEPTIC SORE THROAT MAX 
phenol and glycerin spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1749
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (PHENOL) PHENOL1.5 mg  in 100 mL
GLYCERIN (GLYCERIN) GLYCERIN33 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
WATER 
SACCHARIN SODIUM 
SUCRALOSE 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0295-1749-051 BOTTLE, DISPENSING in 1 BOX
130 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35601/01/2017
Labeler - Denison Pharmaceuticals, Inc. (001207208)
Establishment
NameAddressID/FEIOperations
Denison Pharmaceuticals, Inc.001207208MANUFACTURE(0295-1749)

 
Denison Pharmaceuticals, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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