TOPCARE COLD AND HOT PAIN RELIEVING  ANALGESIC- lidocaine hydrochloride and menthol, unspecified form cream 
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® Cold & Hot Pain Relieving Cream
Topical Analgesic

Drug Facts

Active ingredientsPurpose
Lidocaine HCl 4%Topical analgesic
Menthol 1%Topical analgesic

Use

temporarily relieves minor pain

Warnings

For external use only

Do not use

on large areas of the body or on cut, irritated or swollen skin
on puncture wounds
for more than one week without consulting a doctor

When using this product

use only as directed. Read and follow all directions and warnings on this carton
rare cases of serious burns have been reported with products of this type
do not bandage or apply local heat (such as heating pads) to the area of use with a medicated patch
avoid contact with eyes and mucous membranes
a transient burning sensation may occur upon application but generally disappears in several days

Discontinue use and consult a doctor if

condition worsens
redness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again within a few days
you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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 (1-800-222-1222) immediately.

Directions

Adults and children over 12 years:

Apply to affected area not more than 3 to 4 times daily
AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children under 12 years or younger: ask a doctor

Other information

store at room temperature

Inactive ingredients

acrylates/C10-30 alkyl Acrylate crosspolymer, alcohol denat., aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polysorbate 60, steareth-21, water.

Questions or comments?

1-888-423-0139

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton

TopCare®
health

COMPARE TO ICY HOT® ACTIVE INGREDIENTS*

MAXIMUM STRENGTH LIDOCAINE

Cold & Hot
Pain Relieving
Lidocaine Cream

4% Lidocaine • 1% Menthol

LIDOCAINE 4% / TOPICAL ANALGESIC
MENTHOL 1% / TOPICAL ANALGESIC

NET WT 2.7 OZ (77 g)

PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton
TOPCARE COLD AND HOT PAIN RELIEVING   ANALGESIC
lidocaine hydrochloride and menthol, unspecified form cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-180
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
C30-45 Alkyl Cetearyl Dimethicone Crosspolymer (UNII: 4ZK9VP326R)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Ceteth-20 Phosphate (UNII: 921FTA1500)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
Dimethicone (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Ethylhexylglycerin (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
Isohexadecane (UNII: 918X1OUF1E)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Steareth-21 (UNII: 53J3F32P58)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-180-011 in 1 CARTON05/24/2022
177 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/24/2022
Labeler - Topco Associates, LLC (006935977)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries INC.255106239MANUFACTURE(76162-180)

Revised: 8/2022
Document Id: 5d5565af-f998-489d-9442-a33ec6679d95
Set id: e5ed6c88-5b78-449a-adb6-861d6f1d1f4a
Version: 5
Effective Time: 20220802
 
Topco Associates, LLC