Chloraseptic Sore Throat

Dosage form: spray
Ingredients: PHENOL 3.5mg in 0.7mL
Labeler: Prestige Brands Holdings, Inc.
NDC Code: 67172-935

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 Grape Spray

Drug Facts

Active ingredient

Phenol 0.5%

Purpose

Oral Anesthetic/Analgesic

Uses

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.

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 in the use of this product. Children under 3 years of age: consult a doctor or dentist.

Other information
  • Store at room temperature.
  • Tamper Evident: Do not use if imprinted shrink band is broken or missing.
  • Check expiration date before using.

Inactive ingredients

FD&C Blue #1, FD&C Red #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)

CHLORASEPTIC SORE THROAT 
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-935
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (PHENOL) PHENOL3.5 mg  in 0.7 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
WATER 
GLYCERIN 
SODIUM CHLORIDE 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67172-935-51177 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34809/01/2010
Labeler - Prestige Brands Holdings, Inc. (159655021)
Establishment
NameAddressID/FEIOperations
Denison Pharmaceuticals, Inc.001207208MANUFACTURE(67172-935)

Revised: 03/2013
 
Prestige Brands Holdings, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)