TOPCARE COLD AND HOT MEDICATED- menthol patch

Topcare Cold and Hot Medicated by

Drug Labeling and Warnings

Topcare Cold and Hot Medicated by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

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

PURPOSE

Uses

• temporarily relieves minor aches and pains of muscles and joints associated with:
• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like-conditions

ASK DOCTOR

Ask a doctor before use if you have

redness over the affected area

WHEN USING

When using this product

• use only as directed
• avoid contact with eyes or mucous membranes
• do not bandage tightly
• discontinue use at least 1 hour before a bath or shower
• do not use immediately after a bath or shower

STOP USE

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation occurs

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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

INDICATIONS & USAGE

Directions

• open pouch and remove patch
• carefully peel off protective backing and apply sticky side to affected area
• adults and children 12 years of age and older:
• do not wear patch for more than 8 hours
• apply to affected area no more than 3 times daily
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

DOSAGE & ADMINISTRATION

Distributed by:

Topco Associates LLC

Elk Grove Village, IL 60007

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE COLD AND HOT MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-860
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALCOHOL (UNII: 3K9958V90M)
KAOLIN (UNII: 24H4NWX5CO)
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-860-05	5 in 1 BOX	04/23/2019
1		1 in 1 PATCH; 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	04/23/2019

Labeler - Topco Associates LLC (006935977)