SPL v1
SPL
SPL Set ID eb83a3dd-557e-4334-b806-5fc05e9175a3
Route
TOPICAL
Published
Effective Date 2025-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Allantoin Aloe Vera Leaf Water Carbomer Cetostearyl Alcohol Ethylhexylglycerin Glycerin Glyceryl Stearate Se Helianthus Annuus Flowering Top Phenoxyethanol Polysorbate 20 Polysorbate 60 Simmondsia Chinensis Leaf Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-17

Description

Lidocaine 4%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Lidocaine 4%

Uses

For the temporary relief of pain and itching, associated with minor burns,sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.

Section 50565-1

Warnings

For external Use only

  • Avoid contact with the eyes.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop Use and Ask a Doctor if

  • condition worsens or if symptoms persist for more than 7 days 
  • or occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a doctor.

Product Label

Active Ingredient

Lidocaine 4%

Other Information

Store at room temperature, 20 – 25°C (68-77°F).

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE,Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorabte-20, Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Triethanolamine.


Structured Label Content

Uses

For the temporary relief of pain and itching, associated with minor burns,sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.

Section 50565-1 (50565-1)

Purpose

Topical Analgesic

Warnings

For external Use only

  • Avoid contact with the eyes.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop Use and Ask a Doctor if

  • condition worsens or if symptoms persist for more than 7 days 
  • or occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a doctor.

Product Label (Product label)

Active Ingredient

Lidocaine 4%

Other Information (Other information)

Store at room temperature, 20 – 25°C (68-77°F).

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE,Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorabte-20, Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Triethanolamine.


Advanced Ingredient Data


Raw Label Data

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