Ps-3883 Burn Ease 3.5g

SPL v3

SPL

SPL Set ID 004aa18f-3a97-f454-e063-6394a90afcff

Route

TOPICAL

Published

Effective Date 2023-07-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients

Methylparaben Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Propylene Glycol Propylparaben Water Trolamine Glycerin Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Imidurea Melaleuca Alternifolia (tea Tree) Leaf Oil

Identifiers & Packaging

Pill Appearance

Shape: freeform

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-07-31

Description

Lidocaine Hydrochloride 2%

Purpose

Analgesic

Medication Information

Purpose

Analgesic

Description

Lidocaine Hydrochloride 2%

Label

PS-3883 Burn Ease 3.5g

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 years 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 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.

Structured Label Content

Label

PS-3883 Burn Ease 3.5g

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 (Do not use)

• On wounds or damaged skin

• In large quantities, particularly 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 (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": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "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": "IMIDUREA", "unii": "M629807ATL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Label": "PS-3883 Burn Ease 3.5g", "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, particularly 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:40.497256 · Updated: 2026-03-14T23:11:22.461750