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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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:

Children 12 years or younger: ask a doctor

Other information

Inactive ingredients

aloe barbadensis leaf juice, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium

aluminate metasilicate, methylparaben, peg-40 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric

acid, titanium dioxide, tocopherol acetate

Distributed By:

Dolgencorp. LLC

100 Mission Ridge

Goodlettsville, TN 37072

Made in Korea

image description

DG HEALTH EXTRA STRENGTH MEDICATED 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-395
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL750 mg
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CASTOR OIL (UNII: D5340Y2I9G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
KAOLIN (UNII: 24H4NWX5CO)  
SILODRATE (UNII: 9T3UU8T0QK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
POVIDONES (UNII: FZ989GH94E)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-395-011 in 1 CARTON06/30/2013
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/2013
Labeler - Dolgencorp Inc (068331990)

Revised: 6/2016
Document Id: 3fc75f5b-e4fb-4041-b665-9415ffcd626f
Set id: c18dc368-6e48-4e7a-b1fb-afdd5096b023
Version: 2
Effective Time: 20160601
 
Dolgencorp Inc