CHLORASEPTIC SORE THROAT (KIDS GRAPE) GRAPE- phenol spray

Chloraseptic Sore Throat (Kids Grape) by

Drug Labeling and Warnings

Chloraseptic Sore Throat (Kids Grape) by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC, Denison Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

CHLORASEPTIC SORE THROAT (KIDS GRAPE)  GRAPE
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9355
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	3.5 mg  in 0.7 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9355-23	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/07/2019

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	manufacture(0295-9355)