QUALITY CHOICE ORAL PAIN RELIEF- benzocaine 20%, benzalkonium chloride 1% gel 
Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)

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Quality Choice Oral Pain Relief

Active ingredients

Benzocaine 20%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Antiseptic

Use

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

Do not use

Stop use and ask a physician if

KEEP OUT OF REACH OF CHILDREN:

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

Other information

Inactive ingredients

glycerin, PEG 400, propylene glycol, sorbitol, sodium saccharine, sorbic acid, sodium polyacrylate,strawberry flavor, water

Questions or comments?

TOLL FREE 800-935-2362

label

QUALITY CHOICE ORAL PAIN RELIEF 
benzocaine 20%, benzalkonium chloride 1% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83324-035-121 in 1 CARTON04/01/2024
111.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02204/01/2024
Labeler - Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) (011920774)
Establishment
NameAddressID/FEIBusiness Operations
Astonea Labs Private Label878533295manufacture(83324-035)

Revised: 4/2024
Document Id: 16271ed7-9c13-93e0-e063-6294a90a1adc
Set id: 162702b4-4bf7-8868-e063-6294a90a5921
Version: 1
Effective Time: 20240415
 
Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)