BUDPAK MUSCLE RUB- menthol 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.

----------

Active Ingredient

Menthol 2.5%

Purpose

Topical Analgesic

Uses

Warnings

For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

Directions

Other Information

Inactive Ingredients

Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol,PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide, Water

PRINCIPAL DISPLAY PANEL

BUDPAK MUSCLE RUB

FAST PENETRATING RELIEF

NET WT 1.25 OZ (35 g)

image of package label

BUDPAK MUSCLE RUB 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.025 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ISOCETETH-20 (UNII: O020065R7Z)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-018-011 in 1 BOX
1NDC:27293-018-3535 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34812/17/2012
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-018)

Revised: 11/2012
Document Id: a7f5887e-da34-4842-a601-9aa8e9a398af
Set id: eca2e68f-7c1c-4887-ae6b-fa66b31f535f
Version: 1
Effective Time: 20121124
 
Budpak Inc.