TOPCARE PAIN RELIEVING ANALGESIC- lidocaine hydrochloride cream

TopCare Pain Relieving by

Drug Labeling and Warnings

TopCare Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Garcoa, Inc., Sigan Industries INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton

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

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	03/25/2020

Labeler - Topco Associates LLC (006935977)

Registrant - Garcoa, Inc. (036464697)

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