TOPCARE MEDICATED- menthol patch

TopCare Medicated by

Drug Labeling and Warnings

TopCare Medicated by is a Otc medication manufactured, distributed, or labeled by Top Care. 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 a 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
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• skin irritation develops
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

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

INDICATIONS & USAGE

Directions

• adults and children 12 years of age and older
• peel off protective backing and apply sticky side to affected area
• carefully remove backing from patch
• apply one patch to affected area
• repeat as necessary, but no more than 4 times daily
  
• children under 12 years of age: consult a doctor
  

STORAGE AND HANDLING

Other information

• store at room temperature
  

INACTIVE INGREDIENT

Inactive ingredients aloe barbadensis leaf juice, alumina magnesium metasilicate, aluminum hydroxide, BHT, caster oil, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, tocopherol acetate, sodium polyacrylate, tartaric acid, tianium dioxide. Release Liner: polypropylene. Non-Woven Material: polyester non-woven fabric.

DOSAGE & ADMINISTRATION

Distributed By:

TOPCO Associates LLC

150 Northwest Point Boulevard

Elk Grove Village, IL 60007

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-152
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL (UNII: 532B59J990)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-152-05	1 in 1 CARTON	06/30/2013
1		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/30/2013

Labeler - Top Care (006935977)