PANITROL XR- menthol cream 
Enzyme Labs

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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Menthol 5%

Topical analgesic

For the temporary relief of minor aches and pains associated with:

Aloe, Avocado Oil, Ceteareth-20, Cyclomethicone, Grape Seed Oil, MedFlex Relief Proprietary Herbal Blend, Methyl Glucose Sesquistearate, Natural Oil of Wintergreen, Phenoxyethanol, Methylparaben, Shea Butter, Steareth-2, Steareth-10, Stearic Acid, Water

For external use only.

Do not use

Ask a doctor before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.  If swallowed get medical help or contact a poison center right away.

Directions

store in a cool, dry place away from direct sunlight

Call 1-877-500-5529

Monday through Friday, 9am-5pm or customerservice@enzymelabs.com

Penetrating Pain Relief

Temporary Relief of Minor Aches and Pains Associated with Arthritis, Simple Backache, Sprains, Bruises and Strains.



Panitrol Label


PANITROL  XR
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59940-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.25 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SHEA BUTTER (UNII: K49155WL9Y)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-10 (UNII: FD0913P475)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59940-001-0385 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2010
Labeler - Enzyme Labs (617686980)
Registrant - Enzyme Labs (617686980)
Establishment
NameAddressID/FEIBusiness Operations
Accupack Midwest Inc.139637433manufacture

Revised: 1/2011
Document Id: 35aa8a10-6e71-47a5-8018-a66fffc12c34
Set id: d7fe6680-66f4-41e4-a026-711cc32c4363
Version: 3
Effective Time: 20110101
 
Enzyme Labs