MUSCLE RUB ULTRA STRENGTH PAIN RELIEVING- menthol cream 
Personal Care Products, 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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Active Ingredient

Drug Facts

Menthol 2.5%

Purpose

Topical analgesic

Keep out of reach of children

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

Temporarily relieves the minor aches and pains of muscles and joints associated with:

Warnings

For external use only.

Do not use on

Ask a doctor before use if you have redness over the affected area.

When using this product


Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

camphor, carbomer, DMDM hydantoin,PEG-40 hydrogenated castor oil, isopropyl alcohol, stearic acid, glyceryl monostearate, purified water, sodium hydroxide.

Product Label

DRUGSTORE-Rx

SMART WELLNESS

Ultra Strength

Muscle Rub

Pain Relieving Cream Analgesic


Relieves minor


Fast penetrating

Long lasting

NET WT. 1.5 OZ. (42 g)

DRUGSTORE-Rx

SMART WELLNESS delivers outstanding quality in healthcare products, at truly amazing prices. We employ the highest standard when searching the world to bring the best value to your doorstep. Use our products confidently, knowing that attention and care has gone into every item. That's smart wellness!

Distributed by: PERSONAL CARE PRODUCTS, LLC
Troy, Michigan 48084 U.S.A.

Code No. MH/DRUGS/KD-313               Made in India


PC MuscleRub1 Label

PC MuscleRub4 Label








MUSCLE RUB  ULTRA STRENGTH PAIN RELIEVING
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2433
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.05 g  in 42 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-2433-142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/2013
Labeler - Personal Care Products, Inc. (966155082)
Registrant - Personal Care Products, Inc. (966155082)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(29500-2433)

Revised: 7/2013
Document Id: 8d9b88cc-7bb7-4532-9a07-201713581ea0
Set id: a9d57473-530f-4fc1-979c-28dc82d7c32f
Version: 1
Effective Time: 20130710
 
Personal Care Products, Inc.