FAMILY WELLNESS COLD AND HOT PAIN RELIEF - menthol patch 
FAMILY DOLLAR

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.  Do not use on infants.  If swallowed, get medical help or contact a Poison Control Center immediately

Directions

adults and children over 12 years:

children 12 years of younger:

Inactive ingredients: Aloe Barbadensis Leaf Juice, Aluminum Hydroxide, Disodium EDTA, Gelatin, Kaolin, Methylparaben, Glycerin, Titanium Dioxide, Isopropyl Myristate, Purified Water,

Polyvinyl Pyrrolidone, Peg-4 Stearate, Polyvinyl Alcohol, Polysorbate 80, PVP, Tocopherol Acetate, Alumino Magnesium Metasilicate, Castor Oil, Tartaric Acid, BHT, Sodium Polyacrylate.

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.

10401 MONROE RD.,

MATTHEWS, NC 28105 USA

MADE IN KOREA

image of carton label

FAMILY WELLNESS COLD AND HOT PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-026
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:55319-026-031 in 1 CARTON
13 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/30/2012
Labeler - FAMILY DOLLAR (024472631)

Revised: 11/2012
Document Id: 44a22089-975b-4f32-aa2a-ec2af7b1c0a9
Set id: b7775d35-b724-41dc-a1e3-ebab8da6b563
Version: 1
Effective Time: 20121130
 
FAMILY DOLLAR