MUSCLE RUB- menthol gel 
Universal Distribution Center LLC

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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U Muscle Rub Gel

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

MUSCLE RUB GEL

NET WT 1.25 OZ (35 g)

image of package label

MUSCLE RUB 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-020
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:52000-020-371 in 1 BOX12/13/2020
1NDC:52000-020-3835 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 finalpart34804/15/2015
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-020)

Revised: 2/2022
Document Id: d882ec1c-a98e-693d-e053-2995a90a282d
Set id: 4481b268-8e92-4dab-a376-98db8b360a7c
Version: 3
Effective Time: 20220221
 
Universal Distribution Center LLC