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WinCo Foods Maximum Strength Oral Analgesic

Medically reviewed by Drugs.com. Last updated on Aug 3, 2020.

Dosage form: gel
Ingredients: BENZOCAINE 200mg in 1g
Labeler: WinCo Foods, LLC
NDC Code: 67091-198

WinCo Max. Strength Oral Gel 0.42oz (24115, 2020)

Active ingredient                                                            Purpose

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

Uses

For the temporary relief of pain due to:

  • toothache
  • canker sores
  • gum pain
  • denture pain
  • cheek bites

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

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

  • more than directed
  • for more than 7 days unless directed by a doctor
  • for teething
  • in children under 2 years of age

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness does not go away
  • swelling, rash or fever develops

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

  • 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.

Other information

  • store at room temperature 20-25°C (68-77°F)
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted. Do not use continuously.

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 MAXIMUM STRENGTH ORAL ANALGESIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-198
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 4000 
SACCHARIN SODIUM 
SORBITOL 
PEPPERMINT OIL 
Packaging
#Item CodePackage Description
1NDC:67091-198-111 TUBE in 1 CARTON
111.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/01/2014
Labeler - WinCo Foods, LLC (056098817)

 
WinCo Foods, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.