WINCO FOODS MAXIMUM STRENGTH ORAL ANALGESIC- benzocaine gel

WinCo Foods Maximum Strength Oral Analgesic by

Drug Labeling and Warnings

WinCo Foods Maximum Strength Oral Analgesic by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                            Purpose

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

PURPOSE

Uses

temporarily relieves pain due to toothache, canker sores, cold sores, gum pain, denture pain, cheek bites

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

Allery 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

Do not use

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

ASK DOCTOR

Stop use and ask a doctor if

• swelling, rash, or fever develops
• irritation, pain, or redness persists or worsens
• symptoms do not improve in 7 days

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions

• Adults an 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

STORAGE AND HANDLING

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 can be consulted
• do not use continuously

INACTIVE INGREDIENT

Inactive ingredients

glycerin, mint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

WINCO FOODS, LLC

BOISE, ID 83704

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WINCO FOODS MAXIMUM STRENGTH ORAL ANALGESIC 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-198
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-198-11	1 in 1 CARTON	11/08/2016
1		11.9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/01/2014

Labeler - WinCo Foods, LLC (056098817)