OTC Medication Information: Equate Severe Toothache and Gum Relief

EQUATE SEVERE TOOTHACHE AND GUM RELIEF- benzalkonium chloride, benzocaine and menthol gel
Wal-Mart Stores Inc

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.

Drug Facts

Drug Facts

Active ingredients

Benzocaine 20%

Menthol 0.5%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Oral pain reliever

Antiseptic

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

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 · 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 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. In case of overdose, get medical help or contact a Poison Control Center right away.

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

Polyethylene Glycol, Sodium Saccharin

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

labellabel
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.1 g in 100 g
BENZOCAINE (BENZOCAINE) BENZOCAINE 20 g in 100 g
MENTHOL (MENTHOL) MENTHOL 0.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
PECTIN
GELATIN
MINERAL OIL
FD&C BLUE NO. 1
PETROLATUM
SACCHARIN SODIUM (SACCHARIN)
POLYETHYLENE GLYCOL, UNSPECIFIED
METHYL SALICYLATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49035-361-19 1 TUBE in 1 BOX contains a TUBE
1 7 g in 1 TUBE This package is contained within the BOX (49035-361-19)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 11/02/2018 07/12/2023
Labeler — Wal-Mart Stores Inc (051957769)
Registrant — Lornamead (080046418)
Establishment
Name Address ID/FEI Operations
Lornamead 080046418 manufacture (49035-361)

Revised: 07/2021 Wal-Mart Stores Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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