FAMILY WELLNESS COLD AND HOT PAIN RELIEF- menthol patch

FAMILY WELLNESS COLD AND HOT PAIN RELIEF by

Drug Labeling and Warnings

FAMILY WELLNESS COLD AND HOT PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                               Purpose

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

PURPOSE

Uses temporarily relieves minor pain associated with:

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

WARNINGS

Warnings

For external use only

WHEN USING

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

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
  

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  Do not use on infants.  If swallowed, get medical help or contact a Poison Control Center immediately

INDICATIONS & USAGE

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 INGREDIENT

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.

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.

10401 MONROE RD.,

MATTHEWS, NC 28105 USA

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS COLD AND HOT PAIN RELIEF 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	750 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-026-03	1 in 1 CARTON
1		3 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/30/2012

Labeler - FAMILY DOLLAR (024472631)