Healthwise 4% Lidocaine Cream 2.7 Oz

Healthwise 4% Lidocaine Cream 2.7 Oz
SPL v1
SPL
SPL Set ID f39eb3d0-e153-4f50-85b1-ad5c677d176c
Route
TOPICAL
Published
Effective Date 2025-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Alcohol Dimethicone Aloe Vera Leaf Phenoxyethanol Steareth-21 Ethylhexylglycerin Edetate Disodium Polyacrylic Acid (250000 Mw) Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Steareth-2 Polysorbate 60 Cetostearyl Alcohol Potassium Hydroxide Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Lidocaine HCl 4%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Lidocaine HCl 4%

Use

temporarily relieves minor 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

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

aloe vera extract,cetostearyl alcohol,dimethicone, edetate disodiumanhydrous,ethyl alcohol,ethylhexylglycerin, hydroxyethyl acrylate/sodium acryloyldimethyl tauratecopolymer, iodopropynyl butylcarbamate, monostearin, phenoxyethanol, polyacrylic acid, potassiumhydroxide, 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

temporarily relieves minor 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)

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)

aloe vera extract,cetostearyl alcohol,dimethicone, edetate disodiumanhydrous,ethyl alcohol,ethylhexylglycerin, hydroxyethyl acrylate/sodium acryloyldimethyl tauratecopolymer, iodopropynyl butylcarbamate, monostearin, phenoxyethanol, polyacrylic acid, potassiumhydroxide, 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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