Chloraseptic Sore Throat Max: Package Insert and Label Information

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 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.