fl-3883 - DailyMed Details

fl-3883

SPL v3

SPL

SPL Set ID 0f8e6842-c889-d5d3-e063-6394a90af880

Route

topical

Published

Effective Date 2024-01-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients

water glycerin carbomer copolymer type b (allyl pentaerythritol crosslinked) tea tree oil carbomer homopolymer, unspecified type propylparaben propylene glycol trolamine methylparaben imidurea

Identifiers & Packaging

Pill Appearance

Shape: freeform

Marketing Status

otc monograph drug active Since 2024-01-26

Purpose

Analgesic

Description

Lidocaine Hydrochloride 2%

Medication Information

Warnings

For External Use Only

Purpose

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: Consult a doctor

Other Information

• Store at room temperature

Inactive Ingredients

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

Description

Lidocaine Hydrochloride 2%

Questions?

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

Label

FL-3883

Use(s)

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

Do Not Use

• On wounds or damaged skin

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

Active Ingredient

Lidocaine Hydrochloride 2%

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

Warnings

For External Use Only

Purpose

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: Consult a doctor

Other Information (Other information)

• Store at room temperature

Inactive Ingredients

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

Questions?

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

Label

FL-3883

Use(s)

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

Do Not Use (Do not use)

• On wounds or damaged skin

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

Active Ingredient

Lidocaine Hydrochloride 2%

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

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "809Y72KV36", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IMIDUREA", "unii": "M629807ATL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Label": "FL-3883", "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 years of age: Consult a doctor", "Do not use": "• On wounds or damaged skin • In large quantities, particulary over raw surfaces or blistered areas", "Questions?": "1-888-900-2920 8AM-4PM PST", "Active Ingredient": "Lidocaine Hydrochloride 2%", "Other information": "• Store at room temperature", "Inactive Ingredients": "Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Glycerin, Imidazolidinyl 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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:40.535718 · Updated: 2026-03-14T23:11:23.873993