Fl-3831

Fl-3831
SPL v3
SPL
SPL Set ID 0f52021f-af8a-5b95-e063-6294a90a2c2a
Route
TOPICAL
Published
Effective Date 2024-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Propylene Glycol Glycerin Methylparaben Imidurea Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Propylparaben Water Trolamine Carbomer Homopolymer, Unspecified Type Tea Tree Oil

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-26
Description

Lidocaine Hydrochloride 2%

Purpose

Analgesic

Medication Information

Purpose

Analgesic

Description

Lidocaine Hydrochloride 2%

Label

FL-3831

Use(s)

• For the temporary relief of pain associated with • Minor burns • Sunburn

Warnings

For External Use Only

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 year of age: Consult a doctor

Do Not Use

• On wounds or damaged skin

• In large quantities, particularly over raw surfaces or blistered areas

Questions?

1-888-900-2920 Monday - Friday 8AM-4PM PST

Active Ingredient

Lidocaine Hydrochloride 2%

Other Information

• Store at room temperature

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Glycerin, Imidazolidinly Urea, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Leaf Oil, Triethanolamine

When Using This Product

• Avoid contact with the eyes • Do not bandage tightly

Stop Use and Ask A Doctor If

• Condition worsens • Symptoms persist for more than 7 days • Symptoms clear up and occur again within a few days

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Structured Label Content

Label

FL-3831

Use(s)

• For the temporary relief of pain associated with • Minor burns • Sunburn

Purpose

Analgesic

Warnings

For External Use Only

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 year of age: Consult a doctor

Do Not Use (Do not use)

• On wounds or damaged skin

• In large quantities, particularly over raw surfaces or blistered areas

Questions?

1-888-900-2920 Monday - Friday 8AM-4PM PST

Active Ingredient

Lidocaine Hydrochloride 2%

Other Information

• Store at room temperature

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Glycerin, Imidazolidinly Urea, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tea Tree Leaf Oil, Triethanolamine

When Using This Product (When using this product)

• Avoid contact with the eyes • Do not bandage tightly

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

• Condition worsens • Symptoms persist for more than 7 days • Symptoms clear up and occur again within a few days

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:40.533503 · Updated: 2026-03-14T23:11:23.873993