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Tamper Evident: Do not use if printed shrinkband seal around the neck is broken or missing
MADE IN CANADA
DIST. BY: PROCTER & GAMBLE,
CINCINNATI, OH 45202
Vicks Vapocool Spray
FDA Label NDC 69423-901
19 label sections · Submitted to the FDA by The Procter & Gamble Manufacturing Company · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Vapocool (NDC 69423-901). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, methemoglobinemia warning–, allergy alert:, sore throat warning –, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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 25°C. 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
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)
901 (901)
* Please review the disclaimer below.
