TOPCARE SORE THROAT MENTHOL FLAVOR- phenol spray

Topcare Sore Throat by

Drug Labeling and Warnings

Topcare Sore Throat 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 relieves 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 year of age unless directed by 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 doctor before use.

Keep out of reach of children.

In case of overdose or accidental, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• ▪ Adults and children 12 year 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 or as directed by a doctor or dentist

• ▪ Children under 12 years of age: Should be supervised in 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 Green No.3, D&C Green No. 5, D&C Yellow No.10, flavor, glycerin, purified water, sucralose.

Questions or comments?

1-888-423-0139

Principal Display Panel

TopCare® health™

NDC# 36800-606-06

COMPARE TO THE CHLORASEPTIC® ACTIVE INGREDIENT*

SUGAR FREE

Sore Throat Spray

PHENOL / ORAL ANESTHETIC

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

ASPIRIN FREE

ALCOHOL FREE

MENTHOL FLAVOR

OUR PHARMACIST RECOMMEND

6 FL OZ (177 mL)

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 TORN.

DISTRIBUTED BY TOPCO ASSOCIATESLLC,

ELK GROVE VILLAGE, IL 6007

TOPCO RARA1217

QUESTIONS? 1-888-423-0139

topcare@topco.comwww.tocarebrand.com

INGREDIENTS AND APPEARANCE

TOPCARE SORE THROAT  MENTHOL FLAVOR
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-606
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 GREEN NO. 3 (UNII: 3P3ONR6O1S)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	GREEN (clear)	Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-606-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/06/2019

Labeler - TOPCO ASSOCIATES LLC (006935977)