67510-0681

67510-0681
SPL v7
SPL
SPL Set ID 9ee46a5b-d00c-4254-e053-2995a90aeb3a
Route
TOPICAL
Published
Effective Date 2025-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.4 g) Menthol (0.1 g)
Inactive Ingredients
Carbomer Interpolymer Type A (55000 Cps) Aloe Vera Leaf Aminomethylpropanol Caprylyl Trisiloxane Cyclomethicone 5 Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dihexadecyl Phosphate Dimethicone Edetate Disodium Ethylhexylglycerin Glyceryl Monostearate Isohexadecane Polysorbate 60 Alcohol Steareth-21 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-08

Description

Lidocaine HCl 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine HCl 4%

Uses

Temporarily relieves minor pain

Purposes

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

  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Do Not Use
  • on large areas of the body or on cut, irritated or swollen skin

  • on puncture wounds

  • for more than one week without consulting a doctor
Active Ingredients

Lidocaine HCl 4%

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, cetearyl alcohol(and)dicetyl phosphate(and)ceteth-10 phosphate, cyclopentasiloxane, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, SD alcohol 40 (15%), steareth-21, water

Principal Display Panel

SOUNDBODY



Lidocaine



Plus Menthol



Pain Relieving Cream

When Using This Product
  • Use only as directed. Read and follow all directions and warnings on this label

  • rare cases of serious burns have been reported with products of this type

  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch

  • avoid contact with eyes and mucous membranes

  • a transient burning sensation may occur upon application but generally disappears in several days
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

  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
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

Purposes

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

  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Do Not Use (Do not use)
  • on large areas of the body or on cut, irritated or swollen skin

  • on puncture wounds

  • for more than one week without consulting a doctor
Active Ingredients

Lidocaine HCl 4%

Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, cetearyl alcohol(and)dicetyl phosphate(and)ceteth-10 phosphate, cyclopentasiloxane, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, SD alcohol 40 (15%), steareth-21, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SOUNDBODY



Lidocaine



Plus Menthol



Pain Relieving Cream

When Using This Product (When using this product)
  • Use only as directed. Read and follow all directions and warnings on this label

  • rare cases of serious burns have been reported with products of this type

  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch

  • avoid contact with eyes and mucous membranes

  • a transient burning sensation may occur upon application but generally disappears in several days
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

  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
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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