EQUATE SEVERE TOOTHACHE AND GUM RELIEF- benzocaine, menthol, benzalkonium chloride gel

equate Severe Toothache and Gum Relief by

Drug Labeling and Warnings

equate Severe Toothache and Gum Relief by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Benzocaine 20%

Menthol 0.5%

Benzalkonium Chloride 0.1%

PURPOSE

Purpose

Oral pain reliever

Oral pain reliever

Antiseptic

INDICATIONS & USAGE

Use · for the temporary relief of pain due to toothaches · to help protect against infection of minor oral irritation

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

SPL UNCLASSIFIED SECTION

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

Do not use · more than directed · for more than 7 days unless told to do so by a dentist or doctor · for teething · in children under 2 years of age

STOP USE

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 allergic reaction occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions cut open tip of tube on score mark adults and children 2 years of age and older: apply a small

amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by

a dentist or doctor children between 2 and 12 years of age should be supervised in the use of this product

children under 2 years of age: do not use

OTHER SAFETY INFORMATION

Other information do not use if tip is cut prior to opening 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 this formula

will stay in place for extended duration of relief avoid using toothpaste or drinking soft drinks or fruit juices for at

least one hour after applying

INACTIVE INGREDIENT

Inactive ingredients Blue 1, Cellulose Gum, Gelatin, Methyl Salicylate, Mineral Oil, Pectin, Petrolatum,

Polyethylene Glycol, Sodium Saccharin

PRINCIPAL DISPLAY PANEL

equate

Triple Medicated

Severe Toothache

& Gum Relief

Oral Pain Reliever / Antiseptic

Immediate Relief of Intense Pain

• Maximum strength BENZOCAINE for toothache pain relief
• Antiseptic to help prevent infection
• Soothing menthol for gums

Fast Acting Gel

Compare to Orajel™ Severe Triple Medicated Gel Active Ingredients*

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

DISTRIBUTED BY: Wal-Mart Stores, Inc. Bentonville, AR 72716

*This product is not manufactured or distributed by Church & Dwight Co. Inc., makers of Orajel™.

TAMPER-EVIDENT:

Do not use if tube tip is cut prior to use

INGREDIENTS AND APPEARANCE

EQUATE SEVERE TOOTHACHE AND GUM RELIEF 
benzocaine, menthol, benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-361
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PECTIN (UNII: 89NA02M4RX)
GELATIN (UNII: 2G86QN327L)
MINERAL OIL (UNII: T5L8T28FGP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PETROLATUM (UNII: 4T6H12BN9U)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-361-19	1 in 1 BOX	11/02/2018
1		7 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	11/02/2018

Labeler - Wal-Mart Stores Inc (051957769)