Healthwise Pain Relief Lidocaine Cream

Healthwise Pain Relief Lidocaine Cream
SPL v2
SPL
SPL Set ID 48ecbab9-13e0-d0fa-e063-6294a90a6ff2
Route
TOPICAL
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Alcohol Polyacrylic Acid (250000 Mw) Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Dimethicone Edetate Disodium Anhydrous Glyceryl 1-stearate Steareth-2 Aloe Vera Leaf Polysorbate 60 Phenoxyethanol Steareth-21 Cetostearyl Alcohol Potassium Hydroxide Ethylhexylglycerin Iodopropynyl Butylcarbamate

Identifiers & Packaging

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

Description

Lidocaine HCl 4%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Lidocaine HCl 4%

Use

For the temporarily relief of pain

Warnings

For external use only. Avoid contact with eyes.

Directions

adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

children 12 years or younger: ask a doctor

Do Not Use
  • in large quantities, particularly over raw surfaces or blistered areas
  • on puncture wounds
  • for more than one week without consulting a doctor
Active Ingredient

Lidocaine HCl 4%

Inactive Ingredients

Inactive ingredients

aloe vera extract, cetostearyl alcohol, dimethicone, edetate disodium anhydrous, ethyl alcohol, ethylhexylglycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, iodopropynyl butylcarbamate, monostearin, phenoxyethanol, polyacrylic acid, potassium hydroxide, steareth-2, steareth-21, tween 60, water

Principal Display Panel

When Using This Product
  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to the area of use
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
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 (800-222-1222) right away.


Structured Label Content

Use

For the temporarily relief of pain

Purpose

Topical analgesic

Warnings

For external use only. Avoid contact with eyes.

Directions

adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

children 12 years or younger: ask a doctor

Do Not Use (Do not use)
  • in large quantities, particularly over raw surfaces or blistered areas
  • on puncture wounds
  • for more than one week without consulting a doctor
Active Ingredient (Active ingredient)

Lidocaine HCl 4%

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

aloe vera extract, cetostearyl alcohol, dimethicone, edetate disodium anhydrous, ethyl alcohol, ethylhexylglycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, iodopropynyl butylcarbamate, monostearin, phenoxyethanol, polyacrylic acid, potassium hydroxide, steareth-2, steareth-21, tween 60, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to the area of use
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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