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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TopCare Maximum Strength Pain Relieving Liquid
Topical Analgesic

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

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

OUR PHARMACISTS
RECOMMEND

2.5 FL OZ (74 mL)

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton
TOPCARE MAXIMUM STRENGTH PAIN RELIEVING   ANALGESIC
menthol, unspecified form liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-894
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-894-011 in 1 CARTON03/25/2020
174 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/25/2020
Labeler - Topco Associates LLC (006935977)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries INC.255106239MANUFACTURE(36800-894)

Revised: 1/2022
Document Id: 8c6d8d77-7bc4-45a2-a13e-019adc036ceb
Set id: dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab
Version: 3
Effective Time: 20220127
 
Topco Associates LLC