TOPCARE PAIN RELIEVING  ANALGESIC- lidocaine hydrochloride 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 Pain Relieving Cream
Topical Analgesic

Drug Facts

Active ingredient

Lidocaine HCl 4%

Purpose

Topical analgesic

Uses

for the temporary relief of pain.

Warnings

For external use only

When using this product

♦
avoid contact with eyes
♦
do not apply to wounds or damaged skin
♦
do not bandage tightly
♦
do not use with heating pads or other heating devices
♦
as with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product
♦
do not use in large quantities, particularly over raw surfaces or blistered areas

Discontinue 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.

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 12 years of age and older: apply to affected area not more than 3 to 4 times daily
♦
children under 12 years of age: do not use, consult 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 Stearare SE, Phenoxyethanol, 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

NDC 36800-470-01

TopCare
health®

COMPARE TO ASPERCREME® ODOR FREE WITH 4% LIDOCAINE ACTIVE INGREDIENT*

ODOR FREE
Pain Relieving Cream
with Lidocaine HCl 4%
MAXIMUM STRENGTH
•Temporary Relief of Pain
•Non-Greasy •Fast Acting •With Aloe

NET WT 2.7 OZ (77 g)

• OUR PHARMACISTS •
RECOMMEND

PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton
TOPCARE PAIN RELIEVING   ANALGESIC
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-470
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
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Alcohol (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Aminomethylpropanol (UNII: LU49E6626Q)  
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 Stearate SE (UNII: FCZ5MH785I)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Steareth-21 (UNII: 53J3F32P58)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-470-011 in 1 CARTON03/25/2020
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 FINALpart34803/25/2020
Labeler - Topco Associates LLC (006935977)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries INC.255106239MANUFACTURE(36800-470)

Revised: 1/2022
Document Id: 3ced0ad1-110f-4510-a758-2f538796586f
Set id: 6b4783e0-1987-4838-9e8c-b95426d62b28
Version: 3
Effective Time: 20220127
 
Topco Associates LLC