TOPCARE CHERRY FLAVOR- phenol spray

TopCare by

Drug Labeling and Warnings

TopCare by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

Uses

For the temporarily 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 a doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor.

When using this product,

do not exceed recommended dosage.

Stop use and ask a dentist or 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.

In case of overdose or accidental poisoning, 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 affected area (one spray)
  • ▪ allow to remain in place for at least 15 seconds, then spit out
  • ▪ use every 2 hours as directed by a doctor or dentist
• ▪ Children under 12 years of age: should be supervised in the use of this product
• ▪ Children under 6 years of age, Ask 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?

1-888-423-0139

Principal Display Panel

TopCare® health™

COMPARE TO CHLORASEPTIC® ACTIVE INGREDIENT*

NDC# 36800-600-06

SUGAR-FREE

Sore Throat Spray

PHENOL/ORAL ANESTHETIC

• Works on Contact
• Relieves Sore Throat Pain
• Fast Acting

ASPIRIN-FREE

ALCOHOL-FREE

CHERRY FLAVOR

6 FL OZ (177 mL)

OUR PHARMACIST RECOMMEND

QUALITY GUARANTEED

*This product is not manufactured or distributed by Prestige Brands, Co., distributor of Chloraseptic®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR MISSING

DISTRIBUTED BY

TOPCO ASSOCIATES LLC,

ELK GROVE VILLAGE, IL 6007

TOPCO RARA1217

QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

Package Label

TopCare Sore Throat Spray Cherry Flavor

INGREDIENTS AND APPEARANCE

TOPCARE  CHERRY FLAVOR
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-600
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	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-600-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/05/2019

Labeler - TOPCO ASSOCIATES, LLC (006935977)