Your browser does not support JavaScript! FAMILY WELLNESS COLD AND HOT PAIN RELIEF (MENTHOL) PATCH [FAMILY DOLLAR]
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FAMILY WELLNESS COLD AND HOT PAIN RELIEF (menthol) patch
[FAMILY DOLLAR]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient                                                               Purpose

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

Uses temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings

For external use only

When using this product:

  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if:

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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:

  • carefully remove backing from patch
  • apply sticky side of patch to affected area
  • repeat as necessary, but no more than 4 times daily
children 12 years of younger:
  • ask a doctor

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 DRUG LABELItem Code (Source)NDC:55319-026
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL750 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
EDETATE DISODIUM 
GELATIN 
KAOLIN 
METHYLPARABEN 
GLYCERIN 
TITANIUM DIOXIDE 
ISOPROPYL MYRISTATE 
WATER 
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
 
FAMILY DOLLAR

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