THERACARE MAXIMUM STRENGTH ORAL PAIN RELIEF SEVERE- benzocaine 20%, benzalkonium chloride 1% gel 
Veridian Healthcare

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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TheraCare Maximum Strength Oral Pain Relief

Active ingredients

Benzocaine 20%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Antiseptic

Use

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

Stop use and ask a physician if

KEEP OUT OF REACH OF CHILDREN:

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

Directions

Other information

Inactive ingredients

Glycerin, polyethylene glycol, saccharin sodium, sodium polyacrylate, sorbic acid, sorbitol, strawberry furanone, water.

Questions or comments?

TOLL FREE 866-326-1313 M-F 8:30 am-4:30 pm CST

label

THERACARE MAXIMUM STRENGTH ORAL PAIN RELIEF  SEVERE
benzocaine 20%, benzalkonium chloride 1% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-201-011 in 1 CARTON02/01/2022
19.35 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 finalpart35602/01/2022
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(71101-201)

Revised: 10/2022
Document Id: eb7928eb-82fe-46c4-e053-2a95a90aa268
Set id: d8270f1c-b44e-ae00-e053-2a95a90aa409
Version: 2
Effective Time: 20221020
 
Veridian Healthcare