Pain Relief Cream With Lidocaine 4%

Pain Relief Cream With Lidocaine 4%
SPL v1
SPL
SPL Set ID 46a2276f-9da0-4e41-92f0-b17c302c7222
Route
TOPICAL
Published
Effective Date 2025-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.4 g)
Inactive Ingredients
Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Aloe Vera Leaf Juice Trolamine C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Cetearyl Alcohol Dimethocaine Edetate Disodium Ethylhexylglycerin Glyceryl Monostearate Methylparaben Isopropyl Alcohol Steareth-21 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-03

Description

Lidocaine HCI 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine HCI 4%

Uses

temporarily relieves minor pain

Warnings

For external use only

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 and younger: ask a doctor

Do Not Use
  • on puncture wounds
  • on large areas of the body or on cut, irritated or swollen skin
  • for more than one week without consulting a doctor
Drug Facts

Package Label

Active Ingredient

Lidocaine HCI 4%

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer,, Aloe Vera Leaf Juice, Trolamine, C30-45 alkyl cetearyl dimethicone crosspolymer, Cetearyl Alcohol, Dimethocane, Edetate Disodium, Ethylhexylglycerin, Glyceryl Monostearate, Methylparaben, Isopropyl Alcohol, Steareth-21, Purified Water

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 and mucous membranes
  • do not bandage or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
Stop Use and Ask A Doctor If
  • condition worsens
  • redness is present
  • irritation develops
  • 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 and Pets.

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


Structured Label Content

Uses

temporarily relieves minor pain

Purpose

Topical anesthetic

Warnings

For external use only

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 and younger: ask a doctor

Do Not Use (Do not use)
  • on puncture wounds
  • on large areas of the body or on cut, irritated or swollen skin
  • for more than one week without consulting a doctor
Drug Facts

Package Label

Active Ingredient

Lidocaine HCI 4%

Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer,, Aloe Vera Leaf Juice, Trolamine, C30-45 alkyl cetearyl dimethicone crosspolymer, Cetearyl Alcohol, Dimethocane, Edetate Disodium, Ethylhexylglycerin, Glyceryl Monostearate, Methylparaben, Isopropyl Alcohol, Steareth-21, Purified Water

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 and mucous membranes
  • do not bandage or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • redness is present
  • irritation develops
  • 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 and Pets. (Keep out of reach of children and pets.)

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


Advanced Ingredient Data


Raw Label Data

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