Drugplain

Quality Choice Maximum Strength Oral Pain Relieving 20 g/100g

BENZOCAINE · GEL · Chain Drug Marketing Association Inc

No Recall History
Plain English

Quality Choice Maximum Strength Oral Pain Relieving is a gel containing benzocaine at 20 g/100g, taken topical. Manufactured by Chain Drug Marketing Association Inc.

Key Facts

Brand Name
Quality Choice Maximum Strength Oral Pain Relieving
Generic Name
BENZOCAINE
NDC Code (Product)
63868-953
Manufacturer
Chain Drug Marketing Association Inc
Strength
20 g/100g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
05/31/2013

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 C.D.M.A., Inc. 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com Made in South Korea

Warnings

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 your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Frequently Asked Questions

What is Quality Choice Maximum Strength Oral Pain Relieving used for?

Quality Choice Maximum Strength Oral Pain Relieving contains BENZOCAINE. It is a gel taken topical. Consult your doctor for specific uses.

Is Quality Choice Maximum Strength Oral Pain Relieving a controlled substance?

Quality Choice Maximum Strength Oral Pain Relieving is not classified as a controlled substance by the DEA.

What is the generic name for Quality Choice Maximum Strength Oral Pain Relieving?

The generic name for Quality Choice Maximum Strength Oral Pain Relieving is BENZOCAINE. There are 12 other brand versions of BENZOCAINE.

What is the NDC code for Quality Choice Maximum Strength Oral Pain Relieving 20 g/100g?

The NDC (National Drug Code) for Quality Choice Maximum Strength Oral Pain Relieving 20 g/100g is 63868-953, listed by Chain Drug Marketing Association Inc.