TOPCARE PAIN RELIEVING CREAM- lidocaine hcl 4% cream

TopCare Pain Relieving Cream by

Drug Labeling and Warnings

TopCare Pain Relieving Cream by is a Otc medication manufactured, distributed, or labeled by Topco Associates, LLC, Weeks & Leo Co., Inc., WEEKS & LEO COMPANY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 4%

INDICATIONS & USAGE

temporarily relieves minor pain

PURPOSE

Topical analgesic

WARNINGS

For external use only

In large quantities, particularly over raw surfaces or blistered areas

Stop use

• condition gets worse
• symptoms last for more than 7 days
• symptoms clear up and occur again within a few days

do not get into eyes

• condition gets worse
• symptoms last for more than 7 days
• symptoms clear up and occur again within a few days

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
• children under 2 years: do not use, consult a doctor.

Other information

store at controlled room temperature 20°-25°C (68°-77°F)

INACTIVE INGREDIENT

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,
C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

PRINCIPAL DISPLAY PANEL

TopCare Health

Fragrance-free

Pain Relieving Cream

with Lidocaine HCl 4% Topical Analgesic

Maximum Strength

Temporary Relief of Pain

Non-Greasy

Fast Acting

with Aloe

Net Wt 2.7oz (76.5g)

INGREDIENTS AND APPEARANCE

TOPCARE PAIN RELIEVING CREAM 
lidocaine hcl 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-291
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
METHYLPARABEN (UNII: A2I8C7HI9T)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)
EDETATE DISODIUM (UNII: 7FLD91C86K)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
DICETYL PHOSPHATE (UNII: 2V6E5WN99N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
STEARETH-21 (UNII: 53J3F32P58)
ALCOHOL (UNII: 3K9958V90M)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
WATER (UNII: 059QF0KO0R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-291-02	1 in 1 CARTON	01/30/2026
1		76.5 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 Drug	M017	01/30/2026

Labeler - Topco Associates, LLC (006935977)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
WEEKS & LEO COMPANY, INC.		005290028	manufacture(76162-291)