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Chloraseptic Sore Throat Spray: Package Insert / Prescribing Info

Package insert / product label
Generic name: phenol
Dosage form: oral spray

Drug Facts

Active ingredient

Phenol 0.5%

Purpose

Oral Anesthetic/Analgesic

Indications and Usage for Chloraseptic Sore Throat Spray

For the temporary relief of occasional minor irritation, pain, 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 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.

Stop use and ask a doctor or dentist if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

If pregnant or breast-feeding, ask a health care professional 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.

Chloraseptic Sore Throat Spray Dosage and Administration

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 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 rlueno. 1, FD&C red no.40, flavor, glycerin, purified water, sodium saccharin, sodium chloride

Questions?

1-800-552-7932 www.chloraseptic.com

PRINCIPAL DISPLAY PANEL

Kids Chloraseptic® Phenol/Oral Anesthetic
SORE THROAT
Real Relief, Real Fast®
GRAPE | 6 fl oz (177 mL)

Description: PRINCIPAL DISPLAY PANEL
Kids Chloraseptic® 
Phenol/Oral Anesthetic

CHLORASEPTIC SORE THROAT
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-935
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL3.5 mg in 0.7 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Product Characteristics
ColorPURPLEScore
ShapeSize
FlavorGRAPEImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67172-935-51177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/01/2010
Labeler - Prestige Brands Holdings, Inc. (159655021)