Lidocaine 4% Plus Menthol 1% Pain Relief Cream

Lidocaine 4% Plus Menthol 1% Pain Relief Cream
SPL v1
SPL
SPL Set ID 3c723fdf-cb6d-53b0-e063-6294a90a1339
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (1 g) Menthol (4.27 g)
Inactive Ingredients
Polysorbate 80

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Lidocaine 4% Menthol 1%

Dosage and Administration

Adults and children 2 years and older. Apply externally to the affected area up to 3 to 4 times a day. Children under 2 years of age. Consult a doctor.


Medication Information

Dosage and Administration

Adults and children 2 years and older. Apply externally to the affected area up to 3 to 4 times a day.

Children under 2 years of age. Consult a doctor.

Description

Lidocaine 4% Menthol 1%

Uses

temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites
Usage

Lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites.



Lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas.

Warnings

For external use only.

Directions

• Adults and children 2 years and

older: apply externally to the

affected area up to 3-4 times a day.

• Children under 2 years of age:

consult a doctor.

Package Label

Other Information

• Store at USP controlled room

temperature 20-25°C (68-77°F).

Active Ingredients

Lidocaine 4%

Menthol 1%

Inactive Ingredients

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin,

polysorbate 80, propylene glycol, tocopheryl acetate, trolamine,

water.

When Using This Product



• do not use in or near the eyes

• do not use in large quantities, particularly over raw surfaces or

blistered area

Stop Use and Ask A Doctor If

• allergic reaction occurs

• condition worsens or does not

improve within 7 days

• symptoms clear up and return

within a few days

• redness, irritation, swelling, pain or

other symptoms begin or increase

Keep Out of Reach of Children.

If swallowed, get medical help or

contact a Poison Control Center

right away.


Structured Label Content

Uses

temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites
Usage

Lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites.



Lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas.

Warnings

For external use only.

Directions

• Adults and children 2 years and

older: apply externally to the

affected area up to 3-4 times a day.

• Children under 2 years of age:

consult a doctor.

Package Label

Other Information (Other information)

• Store at USP controlled room

temperature 20-25°C (68-77°F).

Active Ingredients

Lidocaine 4%

Menthol 1%

Inactive Ingredients

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin,

polysorbate 80, propylene glycol, tocopheryl acetate, trolamine,

water.

When Using This Product (When using this product)



• do not use in or near the eyes

• do not use in large quantities, particularly over raw surfaces or

blistered area

Dosage and Administration

Adults and children 2 years and older. Apply externally to the affected area up to 3 to 4 times a day.

Children under 2 years of age. Consult a doctor.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• allergic reaction occurs

• condition worsens or does not

improve within 7 days

• symptoms clear up and return

within a few days

• redness, irritation, swelling, pain or

other symptoms begin or increase

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

If swallowed, get medical help or

contact a Poison Control Center

right away.


Advanced Ingredient Data


Raw Label Data

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