7775bfdd-7eac-4f09-b83f-fc4a16a24558

SPL v5
SPL
SPL Set ID 7775bfdd-7eac-4f09-b83f-fc4a16a24558
Route
topical
Published
Effective Date 2026-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
aloe vera leaf water carbomer homopolymer, unspecified type cetostearyl alcohol ethylhexylglycerin glycol stearate glyceryl monostearate sunflower oil phenoxyethanol polysorbate 60 jojoba oil stearic acid trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2025-01-13 Until 2025-12-31

Purpose

Topical Analgesic

Description

Lidocaine 4%


Medication Information

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.

Purpose

Topical Analgesic

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.

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.

Description

Lidocaine 4%

Warning

Warnings for External Use only

  • Avoid contact with eyes
  • Do not use in large quantities, particularly over raw surface or blistered area



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.



Purposes

Topical Analgesic

Product Label

Active Ingredient

Lidocaine 4%

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

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.

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.

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.

Warning

Warnings for External Use only

  • Avoid contact with eyes
  • Do not use in large quantities, particularly over raw surface or blistered area



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.



Purposes

Topical Analgesic

Product Label (Product label)

Active Ingredient

Lidocaine 4%

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)