TOPCARE MAXIMUM STRENGTH PAIN RELIEVING ANALGESIC- menthol, unspecified form liquid

TopCare Maximum Strength Pain Relieving by

Drug Labeling and Warnings

TopCare Maximum Strength Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Garcoa, Inc., Sigan Industries INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Menthol 16%

Purpose

Topical analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with:

• ♦ simple backache
• ♦ arthritis
• ♦ strains
• ♦ bruises
• ♦ sprains

Warnings

For external use only. Test on a small patch of skin before applying generously.

When using this product

• ♦ use only as directed
• ♦ avoid contact with the eyes and mucous membranes
• ♦ do not apply to wounds or damaged skin
• ♦ do not bandage tightly
• ♦ do not use with heating pads or other heating devices
• ♦ if redness is present, discontinue use and consult a doctor
• ♦ if skin irritation occurs, discontinue use
• ♦ a transient burning sensation may occur upon application but generally disappears in several days

Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable

• ♦ keep away from fire or flame

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800222-1222) immediately.

Directions

adults and children 12 years of age and older:

• ♦ apply generously to affected area
• ♦ massage into painful area until thoroughly absorbed into skin
• ♦ repeat if necessary, but not more than 3 to 4 times daily
• ♦ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Children 12 years or younger: ask a doctor

Other information

store at room temperature

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., capsaicin, citric acid, glycerin, isopropyl myristate, propylene glycol, water.

Questions or comments?

1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

NDC: 36800-894-01

TopCare
health®

COMPARE TO ICY HOT® ACTIVE INGREDIENT*

MAXIMUM STRENGTH

Cool n' Heat
Roll-On Liquid

External Analgesic
with Menthol 16%

STAIN FREE

• Powerful, Fast &
  Effective Pain Relief
• No-Mess Applicator
• Keeps Hands Clean

OUR PHARMACISTS
RECOMMEND

2.5 FL OZ (74 mL)

INGREDIENTS AND APPEARANCE

TOPCARE MAXIMUM STRENGTH PAIN RELIEVING   ANALGESIC
menthol, unspecified form liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-894
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
Alcohol (UNII: 3K9958V90M)
Capsaicin (UNII: S07O44R1ZM)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-894-01	1 in 1 CARTON	03/25/2020
1		74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/25/2020

Labeler - Topco Associates LLC (006935977)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(36800-894)