SORE THROAT- phenol spray

SORE THROAT by

Drug Labeling and Warnings

SORE THROAT by is a Otc medication manufactured, distributed, or labeled by Raritan Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Phenol 1.4%

Purpose

Oral pain reliever

Use(s)

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 that accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age unless directed by doctor.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor 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 doctor before use.

Keep out of reach of children

If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Directions

• ▪ Adults and children 12 years of age and older:
  Apply to the affected area (one spray). Allow to remain in place for at least 15 seconds, and then spit out.
• ▪ Use every 2 hours or as directed by a doctor or dentist.
• ▪ Children 6 years to under 12 years of age: should be supervised in the use of this product.
• ▪ Children under 6 years: Consult a doctor or dentist.

Other Information

• Store at room temperature
• Check expiration date before using.

Inactive Ingredients

FD&C Red No. 40, flavor, glycerin, purified water, sucralose

Questions or comments?

1-866-467-2748

Principal Display Panel

*Compare to the active ingredient in Chloraseptic®

NDC# 68163-703-06

SORE THROAT SPRAY

Phenol/Oral Pain Reliever

Fast Acting

Numbs on Contact

SUGAR-FREE

ASPIRIN-FREE

NATURAL CHERRY FLAVOR

6 FL OZ (177 mL)

Tamper-Evident: Do not use if imprinted shrink band is broken or missing.

Distributed by:

*This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Chloraseptic®.

INGREDIENTS AND APPEARANCE

SORE THROAT 
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-703
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	1.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY (Natural Cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-703-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	07/29/2020

Labeler - Raritan Pharmaceuticals Inc (127602287)