TOPCARE COLD AND HOT PAIN RELIEVING ANALGESIC- lidocaine hydrochloride and menthol, unspecified form cream

TopCare Cold and Hot Pain Relieving by

Drug Labeling and Warnings

TopCare Cold and Hot 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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

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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 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

• Helps to Numb Away Pain
• Non-Greasy
• Maximum Strength External
  Analgesic with 4% Lidocaine

NET WT 2.7 OZ (77 g)

INGREDIENTS AND APPEARANCE

TOPCARE COLD AND HOT PAIN RELIEVING   ANALGESIC
lidocaine hydrochloride and menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-180
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
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 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)
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-180-01	1 in 1 CARTON	05/24/2022
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	05/24/2022

Labeler - Topco Associates, LLC (006935977)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(76162-180)