CHLORASEPTIC SORE THROAT (KIDS GRAPE) GRAPE- phenol spray 
Denison Pharmaceuticals, LLC

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.

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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.
  • Check expiration date before using.

Inactive ingredients

FD&C blue no. 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)

label

CHLORASEPTIC SORE THROAT (KIDS GRAPE)  GRAPE
phenol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9355
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:0295-9355-23177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/07/2019
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, Inc.001207208manufacture(0295-9355)

Revised: 3/2019
Document Id: 8381a7c2-89af-2207-e053-2a91aa0ab824
Set id: 8381df7f-ac7e-93fd-e053-2a91aa0a2da8
Version: 1
Effective Time: 20190307
 
Denison Pharmaceuticals, LLC