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

Purpose

Topical anesthetic

Description

Lidocaine HCI 4%


Medication Information

Warnings

For external use only

Uses

temporarily relieves minor pain

Purpose

Topical anesthetic

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

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

Description

Lidocaine HCI 4%

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%

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

Warnings

For external use only

Uses

temporarily relieves minor pain

Purpose

Topical anesthetic

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

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

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%

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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