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

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5820361 equate Severe Toothache & Gum Relief

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

label

EQUATE SEVERE TOOTHACHE AND GUM RELIEF 
benzocaine, menthol, benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-361
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-361-191 in 1 BOX11/02/2018
17 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 finalpart35611/02/201807/12/2023
Labeler - Wal-Mart Stores Inc (051957769)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(49035-361)

Revised: 7/2021
 
Wal-Mart Stores Inc