OTC Medication Information: Chloraseptic Sore Throat Max

CHLORASEPTIC SORE THROAT MAX- phenol and glycerin spray
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.

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

Chloraseptic® Max Sore Throat
Phenol Oral Anesthetic /Demulcent Spray  1 fl oz (30 mL) | Wild Berries
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOL (PHENOL) PHENOL 15 mg in 1 mL
GLYCERIN (GLYCERIN) GLYCERIN 330 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C RED NO. 40
WATER
SACCHARIN SODIUM
SUCRALOSE
Product Characteristics
Color PURPLE Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67172-937-52 1 BOTTLE, DISPENSING in 1 BOX contains a BOTTLE, DISPENSING
1 30 mL in 1 BOTTLE, DISPENSING This package is contained within the BOX (67172-937-52)
2 NDC:67172-937-04 1 BOTTLE, DISPENSING in 1 BOX contains a BOTTLE, DISPENSING
2 118 mL in 1 BOTTLE, DISPENSING This package is contained within the BOX (67172-937-04)
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 Operations
Denison Pharmaceuticals, LLC 001207208 MANUFACTURE (67172-937)

Revised: 01/2021 Prestige Brands Holdings, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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