Drugplain

WinCo Foods Maximum Strength Oral Analgesic 200 mg/g

Benzocaine · GEL · WinCo Foods, LLC

No Recall History
Plain English

WinCo Foods Maximum Strength Oral Analgesic is a gel containing benzocaine at 200 mg/g, taken topical. Manufactured by WinCo Foods, LLC.

Key Facts

Brand Name
WinCo Foods Maximum Strength Oral Analgesic
Generic Name
Benzocaine
NDC Code (Product)
67091-198
Manufacturer
WinCo Foods, LLC
Strength
200 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
12/01/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

methaemoglobinaemia124 reports
drug ineffective89 reports
drug hypersensitivity61 reports
off label use59 reports
asthenia48 reports
nausea47 reports
dyspnoea38 reports
arthralgia36 reports
anxiety35 reports
amnesia33 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Directions Adults and children 2 years of age and older: Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age: Should be supervised in the use of this product. Children under 2 years of age: Do not use.

Dosage & Administration

DISTRIBUTED BY: WINCO FOODS, LLC BOISE, ID 83704 MADE IN CHINA

Warnings

Warnings Methemoglobinemia warning: U se 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 Allery Alert: do not use this product if your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Frequently Asked Questions

What is WinCo Foods Maximum Strength Oral Analgesic used for?

WinCo Foods Maximum Strength Oral Analgesic contains Benzocaine. It is a gel taken topical. Consult your doctor for specific uses.

Is WinCo Foods Maximum Strength Oral Analgesic a controlled substance?

WinCo Foods Maximum Strength Oral Analgesic is not classified as a controlled substance by the DEA.

What is the generic name for WinCo Foods Maximum Strength Oral Analgesic?

The generic name for WinCo Foods Maximum Strength Oral Analgesic is Benzocaine. There are 12 other brand versions of Benzocaine.

What is the NDC code for WinCo Foods Maximum Strength Oral Analgesic 200 mg/g?

The NDC (National Drug Code) for WinCo Foods Maximum Strength Oral Analgesic 200 mg/g is 67091-198, listed by WinCo Foods, LLC.