TOPCARE PAIN RELIEVING ROLL-ON TOPICAL ANALGESIC- menthol, unspecified form gel

TopCare Pain Relieving Roll-On by

Drug Labeling and Warnings

TopCare Pain Relieving Roll-On 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 ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, and sprains

Warnings

For external use only

Ask a doctor before use if you have sensitive skin

When using this product

• Avoid contact with eyes
• Do not apply to wounds or damaged skin
• Do not use with other ointments, creams, sprays or liniments
• Do not apply to irritated skin or if excessive irritation develops
• Do not bandage tightly
• Wash hands after use with cool water
• Do not use with heating pads or heating devices

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 excessive heat or open flame

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Massage not necessary.
• Children under 2 years of age: Consult a doctor.

Other information

Store in a cool dry place with lid closed tightly

Inactive ingredients

aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.

Questions or comments?

1-888-423-0139

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DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label

NDC: 36800-290-01

TopCare
health®

COMPARE TO BIOFREEZE® ROLL-ON ACTIVE INGREDIENT*

Cold Therapy

Pain
Relieving
Roll-On Gel

with Menthol 4%

• For Arthritis, Back Pain,
  Sore Muscles & Joints
• No-Mess Applicator
• Vanishing Scent
• Paraben-Free

OUR PHARMACISTS
RECOMMEND

2.5 FL OZ (74 mL)

INGREDIENTS AND APPEARANCE

TOPCARE PAIN RELIEVING ROLL-ON   TOPICAL ANALGESIC
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-290
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	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Alcohol (UNII: ND2M416302)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Sodium Hydroxide (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
Water (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-290-01	74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	09/03/2020

Labeler - Topco Associates LLC (006935977)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(36800-290)