First Aid Only Burn Gel

SPL v2

SPL

SPL Set ID 9af39fcd-0a57-26d0-e053-2a95a90a99a0

Route

TOPICAL

Published

Effective Date 2019-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients

Tea Tree Oil Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Glycerin Propylene Glycol Imidurea Trolamine Water Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-01-02

Description

Lidocaine Hydrochloride 2%

Purpose

External Analgesic

Medication Information

Purpose

External Analgesic

Description

Lidocaine Hydrochloride 2%

Uses

Temporarily relieves pain associated with minor burns

Section 42229-5

QUESTIONS 800-835-2263

Section 50565-1

Keep out of reach of children.

. If swallowed get medical help or contact Poison Control immediately

Section 51945-4

Warnings

For external use only.

Avoid contact with eyes

Directions

Adults and children 2 years and over:

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

▪ in large quantities, particularly over raw surfaces or blistered areas

• Purpose

External Analgesic

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, Triethanolamine.

• Active Ingredient

Lidocaine Hydrochloride 2%

Stop Use and Ask A Doctor If

▪condition worsens

▪symptoms persist for more than 7 days

▪symptoms clear up and occur again in a few days

Structured Label Content

Uses (USES)

Temporarily relieves pain associated with minor burns

Section 42229-5 (42229-5)

QUESTIONS 800-835-2263

Section 50565-1 (50565-1)

Keep out of reach of children.

. If swallowed get medical help or contact Poison Control immediately

Section 51945-4 (51945-4)

Warnings (WARNINGS)

For external use only.

Avoid contact with eyes

Directions (DIRECTIONS)

Adults and children 2 years and over:

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)

▪ in large quantities, particularly over raw surfaces or blistered areas

• Purpose (• PURPOSE)

External Analgesic

Inactive Ingredients (INACTIVE INGREDIENTS)

Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, Triethanolamine.

• Active Ingredient (• ACTIVE INGREDIENT)

Lidocaine Hydrochloride 2%

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 in a few days

Advanced Ingredient Data

[{"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "71DD5V995L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IMIDUREA", "unii": "M629807ATL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"USES": "Temporarily relieves pain associated with minor burns", "42229-5": "QUESTIONS 800-835-2263", "50565-1": "Keep out of reach of children. . If swallowed get medical help or contact Poison Control immediately", "WARNINGS": "For external use only. Avoid contact with eyes", "DIRECTIONS": "Adults and children 2 years and over: 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": "▪ in large quantities, particularly over raw surfaces or blistered areas", "• PURPOSE": "External Analgesic", "INACTIVE INGREDIENTS": "Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methylparaben, Propylparaben, Propylene Glycol, Purified water, Tea Tree Leaf Oil, Triethanolamine.", "• ACTIVE INGREDIENT": "Lidocaine Hydrochloride 2%", "Stop use and ask a doctor if": "▪condition worsens ▪symptoms persist for more than 7 days ▪symptoms clear up and occur again in a few days"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:26.829827 · Updated: 2026-03-14T23:05:11.503942