drug facts

drug facts
SPL v1
SPL
SPL Set ID 9f02911b-b0be-454a-8889-8307592b6aed
Route
topical
Published
Effective Date 2022-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
aloe vera leaf propylene glycol diazolidinyl urea water menthol .alpha.-tocopherol acetate trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2022-03-18
Purpose

Topical Pain Relief

Description

Lidocaine HCI (2%)

Medication Information

Warnings

For external use only.

Uses

Temporary pain relief of minor burns. For professional use only.

Purpose

Topical Pain Relief

Directions
  • for 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
Other Information
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets
Inactive Ingredients

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

Description

Lidocaine HCI (2%)

Section 50565-1

Keep out of reach of children

If ingested, get medical help or contact a Poison Control Center right away.

Do Not Use
  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens, rinse thoroughly with water
Active Ingredient

Lidocaine HCI (2%)

Questions Or Comments?

1-800-456-7077

Stop Use and Ask A Doctor If
  • condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Principal Display Panel 0.9g Box Label

NDC 70082-500-01

dealmed

Burn

Gel

For temporary relief

of minor burns

144

PACKETS

NET WT. 0.9g

PER PACKET

Principal Display Panel 0.9g Pouch Label

dealmed

Burn Gel

0.9g (1/32 oz.)

Dealmed • Brooklyn, NY

www.dealmed.com

Structured Label Content

Warnings

For external use only.

Uses

Temporary pain relief of minor burns. For professional use only.

Purpose

Topical Pain Relief

Directions
  • for 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
Other Information (Other information)
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets
Inactive Ingredients (Inactive ingredients)

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

Section 50565-1 (50565-1)

Keep out of reach of children

If ingested, get medical help or contact a Poison Control Center right away.

Do Not Use (Do not use)
  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens, rinse thoroughly with water
Active Ingredient (Active ingredient)

Lidocaine HCI (2%)

Questions Or Comments? (Questions or Comments?)

1-800-456-7077

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Principal Display Panel 0.9g Box Label (Principal Display Panel - 0.9g Box Label)

NDC 70082-500-01

dealmed

Burn

Gel

For temporary relief

of minor burns

144

PACKETS

NET WT. 0.9g

PER PACKET

Principal Display Panel 0.9g Pouch Label (Principal Display Panel - 0.9g Pouch Label)

dealmed

Burn Gel

0.9g (1/32 oz.)

Dealmed • Brooklyn, NY

www.dealmed.com

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:09.028502 · Updated: 2026-03-14T23:00:30.367061