TOP CARE MEDICATED- menthol patch

Top Care Medicated by

Drug Labeling and Warnings

Top Care 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
• should be used up to 8 hours
• should be used no more than 3 times daily

children under 12 years of age

• consult a doctor

STORAGE AND HANDLING

Other information

• store at room temperature, not to exceed 86°F (30°C)

INACTIVE INGREDIENT

Inactive Ingredients

1,3- butylene glycol, alove vera (powder), dibutylhydroxytoluene, disodium edetate, d-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purifed water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

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

TOP CARE MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-155
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
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBITOL (UNII: 506T60A25R)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
PARAFFIN (UNII: I9O0E3H2ZE)
MAGALDRATE (UNII: 6V88E24N5T)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-155-05	1 in 1 CARTON	02/07/2017
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	04/21/2014

Labeler - Top Care (006935977)