WINCO FOODS MAXIMUM STRENGTH ORAL ANALGESIC- benzocaine gel 
WinCo Foods, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

WinCo Max. Strength Oral Gel 0.42oz (24115)

Active ingredient                                                            Purpose

Benzocaine 20%........................................................... Oral pain reliever

Uses

For the temporary relief of pain due to:

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:

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.

Do not use

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

DISTRIBUTED BY:

WINCO FOODS, LLC

BOISE, ID 83704

MADE IN CHINA

WinCo Foods Max. Oral Analgesic Gel

WINCO FOODS MAXIMUM STRENGTH ORAL ANALGESIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-198
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-198-111 in 1 CARTON11/08/2016
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 not finalpart35612/01/2014
Labeler - WinCo Foods, LLC (056098817)

Revised: 3/2022
Document Id: db8bc2f1-c053-30ae-e053-2995a90ac857
Set id: c22a7726-8c3f-41bf-b852-8456b2be6f93
Version: 8
Effective Time: 20220331
 
WinCo Foods, LLC