VICKS VAPOCOOL SORE THROAT- benzocaine and menthol spray

Vicks VapoCool by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

Active ingredients

Benzocaine (5 %)
Menthol (1 %)

Purpose

Oral anesthetic

Oral anesthetic

Uses

temporarily relieves occasional minor irritation and pain due to

• sore throat
• sore mouth

Warnings

Methemoglobinemia Warning–

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Allergy alert:

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away.

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.

Do not use

• for teething
• in children under 2

When using this product

do not exceed recommended dosage

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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

Directions

• adults and children 12 years and over: Apply to the affected area (one spray). Gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a doctor.
• children under 12 years, do not use.

Other information

• do not exceed 25ºC. Do not refrigerate.

Inactive ingredients

alcohol, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propylene glycol, purified water, saccharin sodium, sucralose

Questions?

1-800-283-4879

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Tamper Evident: Do not use if printed shrinkband seal around the neck is broken or missing

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MADE IN CANADA

DIST. BY: PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label

VICKS®

VapoCOOL™

SORE THROAT

BENZOCAINE & MENTHOL - ORAL ANESTHETICS

Cooling + Numbing

Soothes Throat Pain
Fast-acting

CHERRY BERRY FREEZE

6 FL OZ (177 ml)

INGREDIENTS AND APPEARANCE

VICKS VAPOCOOL  SORE THROAT
benzocaine and menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-901
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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: 69423-901-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	06/02/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)