BUDPAK BABY TEETHING ORAL PAIN RELIEVER- benzocaine gel 
Budpak 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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Budpak Baby Teething Oral Pain Reliever Gel

Active Ingredient

Benzocaine 7.5%

Purpose

Oral pain reliever

Use

temporarily relieves sore gums due to teething in infants and children 4 months and older

Warnings

Allergy alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Do not use

When using this product

Stop using and ask a dentist or physician if

Keep out of reach of children.

In cases of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive Ingredients

Glycyrrhizin Ammoniated, Glycerin, Polyethylene glycol, Purified water, Sodium saccharin, Sorbic acid, Sorbitol, Flavor, Red #40.

PRINCIPAL DISPLAY PANEL

BUDPAK BABY TEETHING PAIN RELIEVER GEL

Benzocaine 7.5%

NET WT 0.5 OZ. (14 g)

image of package label

BUDPAK BABY TEETHING ORAL PAIN RELIEVER 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITOL (UNII: 506T60A25R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-015-011 in 1 BOX
1NDC:27293-015-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/26/2013
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-015)

Revised: 12/2013
Document Id: b9acba3e-b0e4-483c-b273-e05c674499e9
Set id: be8b7c2a-07f2-41a0-968e-12bf2dcc3ffc
Version: 1
Effective Time: 20131226
 
Budpak Inc.