ORAL PAIN RELIEF- benzocaine gel 
ALAINA HEALTHCARE PRIVATE LIMITED

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MAXIMUM STRENGTH ORAL PAIN RELIEF

Drug Facts

Active ingredients                                                                        Purpose

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

Uses

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:

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:

When using this product:

Stop use and ask doctor if

Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions:

adults and children 2 years of age and over

apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist

children under 12 years of age

adult supervision should be given in the use of this product

children under 2 years of age

do not use

Other information

Inactive Ingredients

benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

ORAL PAIN RELIEF GEL

FAST ACTING

Benzocaine 20% pain relieving gel

NET WT 0.5 OZ (14g)

label

label

ORAL PAIN RELIEF 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73492-717
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73492-717-501 in 1 CARTON12/08/2023
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02212/08/2023
Labeler - ALAINA HEALTHCARE PRIVATE LIMITED (858720927)
Establishment
NameAddressID/FEIBusiness Operations
ALAINA HEALTHCARE PRIVATE LIMITED858720927manufacture(73492-717)

Revised: 12/2023
Document Id: 0c71967e-16fc-4d7b-e063-6294a90a943d
Set id: d98c1b2f-fe75-4d52-b082-1abb7628c59e
Version: 1
Effective Time: 20231213
 
ALAINA HEALTHCARE PRIVATE LIMITED