SPL v1
SPL
SPL Set ID bd1b1873-e900-45eb-96a0-28f782b5a7cd
Route
TOPICAL
Published
Effective Date 2024-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (5 mg)
Inactive Ingredients
Butylated Hydroxytoluene Cetostearyl Alcohol Dimethicone Edetate Disodium Glycerin Glyceryl Monostearate Isopropyl Myristate Polyoxyl 20 Cetostearyl Ether Methylcellulose, Unspecified Water Methylparaben Sodium Propylparaben Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Lidocaine HCL 0.5% Topical Analgesic Benzalkonium Chloride 0.13% Topical Antiseptic

Purpose

Topical Analgesic Topical Antiseptic


Medication Information

Purpose

Topical Analgesic

Topical Antiseptic

Description

Lidocaine HCL 0.5% Topical Analgesic Benzalkonium Chloride 0.13% Topical Antiseptic

Uses

For temporary relief of pain and itching associated with:

  • Sunburn
  • Minor burns,
  • Insect bites,
  • Minor skin irritation,
  • Cuts
  • Scrapes
Warnings

For external use only



Do not use

  • in the eyes 
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns 
  • in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if 

  • the condition gets worse 
  • condition clears up and recurs within a few days 
  • condition persists for more than 7 days
  • If pregnant or breast feeding, ask a health care professional before use.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
  • Adults and children 2 years and over: clean the affected area apply a small amount of this product on the area 3 to 4 times daily may be covered with a sterile bandage
  • Children under 2 years: consult a doctor
Questions?

Contact: 1.848.373.2075

Product Label

Other Information
  • Store at room temperature 
  • tamper evident sealed packets 
  • do not use any opened or torn packets
Active Ingredients

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Inactive Ingredients

Butylated Hydroxytoluene, Cetostearyl Alcohol, Dimethicone, Edetate Disodium, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Macrogol Cetostearyl Ether 20, Methylcellulose, Purified Water, Sodium Methylparaben, Sodium Propylparaben.


Structured Label Content

Uses

For temporary relief of pain and itching associated with:

  • Sunburn
  • Minor burns,
  • Insect bites,
  • Minor skin irritation,
  • Cuts
  • Scrapes
Purpose

Topical Analgesic

Topical Antiseptic

Warnings

For external use only



Do not use

  • in the eyes 
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns 
  • in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if 

  • the condition gets worse 
  • condition clears up and recurs within a few days 
  • condition persists for more than 7 days
  • If pregnant or breast feeding, ask a health care professional before use.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
  • Adults and children 2 years and over: clean the affected area apply a small amount of this product on the area 3 to 4 times daily may be covered with a sterile bandage
  • Children under 2 years: consult a doctor
Questions?

Contact: 1.848.373.2075

Product Label (Product label)

Other Information (Other information)
  • Store at room temperature 
  • tamper evident sealed packets 
  • do not use any opened or torn packets
Active Ingredients

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Inactive Ingredients (Inactive ingredients)

Butylated Hydroxytoluene, Cetostearyl Alcohol, Dimethicone, Edetate Disodium, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Macrogol Cetostearyl Ether 20, Methylcellulose, Purified Water, Sodium Methylparaben, Sodium Propylparaben.


Advanced Ingredient Data


Raw Label Data

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