Hc1 - Lidocaine

Hc1 - Lidocaine
SPL v1
SPL
SPL Set ID 459cedbd-9b6f-e450-e063-6394a90afb73
Route
TOPICAL
Published
Effective Date 2025-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (200 mg)
Inactive Ingredients
Polyethylene Glycol 400 Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-10

Description

Lidocaine 4% Benzalkonium Chloride 0.13%

Purpose

Topical Anesthetic/Analgesic Topical First-Aid Antiseptic


Medication Information

Purpose

Topical Anesthetic/Analgesic

Topical First-Aid Antiseptic

Description

Lidocaine 4% Benzalkonium Chloride 0.13%

Uses

Uses:

  • For the temporary relief of pain
  • First aid to help protect against infection in minor cuts, scrapes, and burns
Warnings
  • For external use only. Do not use In the eyes or apply over large areas of the body, particularly over raw sur1aces or blistered areas. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
  • If condition worsens, or If symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not use longer than 1 week unless directed by a doctor.
  • Flammable. Keep away from fire or flame.
Directions
  • do not exceed recommended dosage

adults and children 2 years of age and older: Clean the affected area. Spray a small amount of this product on the area 1 to 3 times dally. May be covered wtth a sterile bandage. If bandaged, let dry first.

children under 2 years of age: do not use, consult a physician

Do Not Use

Do not Use

  • if foil pouch has been previously opened
  • in children under 2 years of age
Other Information
  • store at 15-30 °C (59-86 °F)
Active Ingredients

Lidocaine 4%

Benzalkonium Chloride 0.13%

Inactive Ingredients

Polyethylene glycol, Ethanol

Questions Or Comments?

1-800-238-4582

M-F: 8:00 a.m. - 4:30 p.m. ET

Principal Display Panel

When Using This Product
  • avoid contact with eyes
Keep Out of Reach of Children.

If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center Immediately


Structured Label Content

Uses

Uses:

  • For the temporary relief of pain
  • First aid to help protect against infection in minor cuts, scrapes, and burns
Purpose

Topical Anesthetic/Analgesic

Topical First-Aid Antiseptic

Warnings
  • For external use only. Do not use In the eyes or apply over large areas of the body, particularly over raw sur1aces or blistered areas. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
  • If condition worsens, or If symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not use longer than 1 week unless directed by a doctor.
  • Flammable. Keep away from fire or flame.
Directions
  • do not exceed recommended dosage

adults and children 2 years of age and older: Clean the affected area. Spray a small amount of this product on the area 1 to 3 times dally. May be covered wtth a sterile bandage. If bandaged, let dry first.

children under 2 years of age: do not use, consult a physician

Do Not Use (Do not use)

Do not Use

  • if foil pouch has been previously opened
  • in children under 2 years of age
Other Information (Other information)
  • store at 15-30 °C (59-86 °F)
Active Ingredients

Lidocaine 4%

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Polyethylene glycol, Ethanol

Questions Or Comments? (Questions or comments?)

1-800-238-4582

M-F: 8:00 a.m. - 4:30 p.m. ET

Principal Display Panel

When Using This Product (When using this product)
  • avoid contact with eyes
Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center Immediately


Advanced Ingredient Data


Raw Label Data

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