4% lidocaine hcl cream

4% lidocaine hcl cream
SPL v2
SPL
SPL Set ID c339dffe-bc9b-4fae-a50f-8db463d244c1
Route
topical
Published
Effective Date 2025-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
acrylates/c10-30 alkyl acrylate crosspolymer (60000 mpa.s) aloe vera leaf juice aminomethylpropanol butylene glycol cetostearyl alcohol ceteth-10 phosphate dihexadecyl phosphate dimethicone, unspecified edetate disodium ethylhexylglycerin glyceryl monostearate hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) phenoxyethanol steareth-21 water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-12
Description

Lidocaine HCl 4%.............................................Topical Analgesic

Medication Information

Warnings

For external use only.

Uses

Temporarily relieves pain and itching due to:

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations
Directions
  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years: Consult a doctor.
Other Information
  • Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F)
Description

Lidocaine HCl 4%.............................................Topical Analgesic

Principal Display Panel

Pain Relief

4% Lidocaaine HCl Cream

Pain Relieving Cream

Topical Analgesic

1.05 oz (30g)

Questions?

Call

Section 50570-1

Do not apply over large areas of the body

Section 55105-1

Drug Facts

Active Ingredient

Lidocaine HCl 4%.............................................Topical Analgesic

Lnactive Lngredients

acrylates/cl0-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, butylene glycol, cetearyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, phenoxyethanol, steareth-21, water

When Using This Product
  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use and Ask A Doctor If
  • Allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase
Keep Out of Reach of Children

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

Structured Label Content

Warnings

For external use only.

Uses

Temporarily relieves pain and itching due to:

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations
Directions
  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years: Consult a doctor.
Other Information (Other information)
  • Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F)
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Pain Relief

4% Lidocaaine HCl Cream

Pain Relieving Cream

Topical Analgesic

1.05 oz (30g)

Questions?

Call

Section 50570-1 (50570-1)

Do not apply over large areas of the body

Section 55105-1 (55105-1)

Drug Facts

Active Ingredient

Lidocaine HCl 4%.............................................Topical Analgesic

Lnactive Lngredients (lnactive lngredients)

acrylates/cl0-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, butylene glycol, cetearyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, phenoxyethanol, steareth-21, water

When Using This Product (When using this product)
  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase
Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:34.139 · Updated: 2026-03-14T23:11:10.262850