Search by Drug Name or NDC

NDC 36800-0470-01 TopCare Pain Relieving 40 mg/g Details

TopCare Pain Relieving 40 mg/g

TopCare Pain Relieving is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	36800-0470
Product ID	36800-470_3ced0ad1-110f-4510-a758-2f538796586f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	TopCare Pain Relieving
Proprietary Name Suffix	Analgesic
Non-Proprietary Name	LIDOCAINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0470-01 (36800047001)

Pricing Information	N/A
NDC Package Code	36800-470-01
Billing NDC	36800047001
Package	1 BOTTLE in 1 CARTON (36800-470-01) / 77 g in 1 BOTTLE
Marketing Start Date	2020-03-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6b4783e0-1987-4838-9e8c-b95426d62b28 Details

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

TOPCARE PAIN RELIEVING ANALGESIC

lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-470
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-470-01	1 in 1 CARTON	03/25/2020
1		77 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	03/25/2020

Labeler - Topco Associates LLC (006935977)

Registrant - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Sigan Industries INC.		255106239	MANUFACTURE(36800-470)

Revised: 1/2022

Document Id: 3ced0ad1-110f-4510-a758-2f538796586f

Set id: 6b4783e0-1987-4838-9e8c-b95426d62b28

Version: 3

Effective Time: 20220127

Search by Drug Name or NDC

NDC 36800-0470-01 TopCare Pain Relieving 40 mg/g Details

TopCare Pain Relieving 40 mg/g

Product Information

Package

Package Images

NDC 36800-0470-01 (36800047001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 6b4783e0-1987-4838-9e8c-b95426d62b28 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

When using this product

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?