Vicks ®VapoCOOL TMHYRDASOOTHE MENTHOL + ORAL ANESTHETIC WINTERFROST MEDICATED DROPS

Vicks VapoCOOL HYDRASOOTHE by

Drug Labeling and Warnings

Vicks VapoCOOL HYDRASOOTHE by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VICKS VAPOCOOL HYDRASOOTHE WINTERFROST- menthol lozenge 
The Procter & Gamble Manufacturing Company

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Vicks ®VapoCOOL TMHYRDASOOTHE
MENTHOL + ORAL ANESTHETIC
WINTERFROST
MEDICATED DROPS

Drug Facts

Active ingredient (per drop)

Menthol 15 mg

Purpose

Oral anesthetic

Uses

relieves occasional minor irritation and pain due to

• sore throat
• sore mouth

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 12 years of age.

Ask a doctor before use if you have

• a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days
• a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting

Stop use and ask a doctor if

• sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens.

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

• adults and children 12 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.
• children 12 years and under: do not use

Other information

• Store at 20°-25°C (68°-77°F) in a dry place
• contains soy

Inactive ingredients

corn syrup, eucalyptol, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, gum arabic, potassium sorbate, sucrose, water

Questions?

1-800-707-1709

DISTRIBUTED BY
PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 20 Medicated Drops

HYDRATING ACTION

VICKS ®

VapoCOOL ™

HYDRASOOTHE

MENTHOL ·ORAL ANESTHETIC

WINTERFROST

Powerful Vicks Vapors
Soothes Sore Throats

20 MEDICATED DROPS

VICKS VAPOCOOL HYDRASOOTHE  WINTERFROST
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-799
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
ACACIA (UNII: 5C5403N26O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
EUCALYPTOL (UNII: RV6J6604TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue (with blue specks)	Score	no score
Shape	OVAL	Size	23mm
Flavor	MENTHOL	Imprint Code	vapor
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-799-20	20 in 1 BAG	02/01/2020	02/28/2024
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 69423-799-50	50 in 1 BAG	02/01/2020	02/28/2024
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	02/01/2020	02/28/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 10/2023

Document Id: 07d86448-2321-e5ae-e063-6294a90a3d61

34390-5

Set id: ef6b81d1-0389-c812-e053-2995a90af0de

Version: 6

Effective Time: 20231016

 

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