Topcare Lidocaine Cream

Topcare Lidocaine Cream
SPL v1
SPL
SPL Set ID 4885a7e6-a127-450a-e063-6294a90a4f91
Route
TOPICAL
Published
Effective Date 2026-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Methylparaben Aminomethyl Propanol Edetate Disodium C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Dicetyl Phosphate Ethylhexylglycerin Steareth-21 Alcohol Aloe Barbadensis Leaf Juice Water Cetearyl Alcohol Dimethicone Glyceryl Monostearate Caprylyl Methicone Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Ceteth-20 Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-30

Description

Lidocaine HCl 4%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

temporarily relieves minor pain

Description

Lidocaine HCl 4%

Section 43683-2

uses:

added temporarily relieves pain.

Directions

Added the required directions

Section 50565-1

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

Section 50566-9
  • condition gets worse
  • symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7

do not get into eyes

Section 50570-1

In large quantities, particularly over raw surfaces or blistered areas

Section 51727-6

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

Section 51945-4

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)

Section 55105-1

Topical analgesic

Section 55106-9

Lidocaine HCl 4%

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


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves minor pain

Warnings and Precautions (34071-1)

For external use only

Section 43683-2 (43683-2)

uses:

added temporarily relieves pain.

Directions

Added the required directions

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)
  • condition gets worse
  • symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7 (50567-7)

do not get into eyes

Section 50570-1 (50570-1)

In large quantities, particularly over raw surfaces or blistered areas

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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)

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Lidocaine HCl 4%

Stop Use (Stop use)
  • condition gets worse
  • symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days
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 (Other information)

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


Advanced Ingredient Data


Raw Label Data

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