Vicks Vapocool sore Throat Benzocaine & Menthol - Oral Anesthetics Spray

Vicks Vapocool sore Throat Benzocaine & Menthol - Oral Anesthetics Spray
SPL v10
SPL
SPL Set ID 8749824b-6d04-430d-e053-2995a90a2db8
Route
ORAL
Published
Effective Date 2023-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (5 g) Menthol (1 g)
Inactive Ingredients
Glycerin Alcohol D&c Yellow No. 10 Sucralose Fd&c Blue No. 1 Propylene Glycol Water Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: turquoise
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-09

Description

Drug Facts

Purpose

Oral anesthetic Oral anesthetic


Medication Information

Purpose

Oral anesthetic

Oral anesthetic

Description

Drug Facts

Uses

temporarily relieves occasional minor irritation and pain due to

  • sore throat
  • sore mouth
Section 34088-5

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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.
Do Not Use
  • for teething
  • in children under 2
Questions?

1-800-283-4879

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.

Other Information
  • do not exceed 25ºC. Do not refrigerate.
Active Ingredients

Benzocaine (5 %)

Menthol (1 %)

Inactive Ingredients

alcohol, D&C Yellow No. 10, FD&C Blue No. 1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sucralose

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.

When Using This Product

do not exceed recommended dosage

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
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.

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
Principal Display Panel 177 Ml Bottle Label

VICKS ®

VapoCOOL

SORE THROAT

BENZOCAINE & MENTHOL - ORAL ANESTHETICS

COOLING + NUMBING

Soothes Throat Pain

Fast-acting

WINTERFROST

6 FL OZ (177 ml)


Structured Label Content

Uses

temporarily relieves occasional minor irritation and pain due to

  • sore throat
  • sore mouth
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Oral anesthetic

Oral anesthetic

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.
Do Not Use (Do not use)
  • for teething
  • in children under 2
Questions?

1-800-283-4879

Allergy Alert: (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.

Other Information (Other information)
  • do not exceed 25ºC. Do not refrigerate.
Active Ingredients (Active ingredients)

Benzocaine (5 %)

Menthol (1 %)

Inactive Ingredients (Inactive ingredients)

alcohol, D&C Yellow No. 10, FD&C Blue No. 1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sucralose

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.

When Using This Product (When using this product)

do not exceed recommended dosage

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
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (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
Principal Display Panel 177 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 177 ml Bottle Label)

VICKS ®

VapoCOOL

SORE THROAT

BENZOCAINE & MENTHOL - ORAL ANESTHETICS

COOLING + NUMBING

Soothes Throat Pain

Fast-acting

WINTERFROST

6 FL OZ (177 ml)


Advanced Ingredient Data


Raw Label Data

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