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

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)

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	09/03/2020

Labeler - Topco Associates LLC (006935977)

Registrant - Garcoa, Inc. (036464697)

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

TopCare Pain Relieving Roll-On Gel Topical Analgesic