DG HEALTH EXTRA STRENGTH MEDICATED  - menthol patch 
DOLGENCORP 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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Drug Facts

Active ingredient                                                             Purpose

Menthol 5%...................................................................Topical analgesic


Uses Temporarily relieves minor pain associated with:

Warnings

For external use only

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 Control Center right away.

Directions adults and children over 12 years

Other information

Inactive ingredients aloe barbadensis leaf juice, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminate metasilicate, methyl paraben, peg-40 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

DISTRIBUTED BY

DOLGEN CORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

MADE IN KOREA

image of carton label

DG HEALTH EXTRA STRENGTH MEDICATED  
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-391
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL750 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-391-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/31/2012
Labeler - DOLGENCORP INC (068331990)

Revised: 12/2012
Document Id: 784b4164-3b17-4e56-bb4e-e872c5fde188
Set id: 132fddd1-d9ab-4097-9e1e-9a8ba3cb4e60
Version: 12
Effective Time: 20121231
 
DOLGENCORP INC