alocane ®

alocane ®
SPL v6
SPL
SPL Set ID 0a33f9a9-1fdc-7cdf-e063-6294a90adca1
Route
topical
Published
Effective Date 2023-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (4 g)
Inactive Ingredients
sodium hydroxide propanediol aloe vera leaf dimethyl isosorbide hydroxyethyl cellulose (5500 mpa.s at 2%) phenoxyethanol .alpha.-tocopherol acetate water ethylhexylglycerin edetate disodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-05-01

Purpose

First Aid Antiseptic External Analgesic

Description

Benzalkonium Chloride 0.13% Lidocaine HCl 4.0%


Medication Information

Warnings

For external use only.

Purpose

First Aid Antiseptic

External Analgesic

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

Aloe Barbadensis (Aloe) Leaf Juice, Dimethyl Isosorbide, Disodium EDTA, Ethylhexyglycerin, Hydroxyethyl Cellulose, Phenoxyethanol, Propanediol, Sodium Hydroxide, Tocopheryl Acetate (Vitamin E), Water.

Description

Benzalkonium Chloride 0.13% Lidocaine HCl 4.0%

Uses:

First aid to help prevent bacterial infection associated with contamination or skin infection, and for the temporary relief of pain and itching associated with minor: :

  • Burns
  • Cuts
  • Sunburn
  • Scrapes
  • Minor Skin Irritations
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Section 50566-9

Stop use and ask doctor: If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50569-3

Ask a doctor before use if you have:

  • Deep or puncture wounds
  • Animal bites
  • Serious burns
Section 50570-1

Do not use:

  • In or near the eyes
  • In large quantities or over large areas of the body
  • On raw surfaces or blistered areas
Section 53414-9

If pregnant or breast-feeding, ask a health care professional before use.

Directions:

Adults and children 2 years of age and older: Clean the affected area. Apply a small amount of gel on the affected area not more than 3 to 4 times daily. May be covered with a sterile bandgae (let dry first).

Children under 2 years of age: ask a doctor.

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 4.0%

24 Count Single Use

Principal Display Panel 2.5 Fl Oz Tube


Structured Label Content

Warnings

For external use only.

Purpose

First Aid Antiseptic

External Analgesic

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

Aloe Barbadensis (Aloe) Leaf Juice, Dimethyl Isosorbide, Disodium EDTA, Ethylhexyglycerin, Hydroxyethyl Cellulose, Phenoxyethanol, Propanediol, Sodium Hydroxide, Tocopheryl Acetate (Vitamin E), Water.

Uses:

First aid to help prevent bacterial infection associated with contamination or skin infection, and for the temporary relief of pain and itching associated with minor: :

  • Burns
  • Cuts
  • Sunburn
  • Scrapes
  • Minor Skin Irritations
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor: If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50569-3 (50569-3)

Ask a doctor before use if you have:

  • Deep or puncture wounds
  • Animal bites
  • Serious burns
Section 50570-1 (50570-1)

Do not use:

  • In or near the eyes
  • In large quantities or over large areas of the body
  • On raw surfaces or blistered areas
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health care professional before use.

Directions:

Adults and children 2 years of age and older: Clean the affected area. Apply a small amount of gel on the affected area not more than 3 to 4 times daily. May be covered with a sterile bandgae (let dry first).

Children under 2 years of age: ask a doctor.

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 4.0%

24 Count Single Use (24 count single use)

Principal Display Panel 2.5 Fl Oz Tube (PRINCIPAL DISPLAY PANEL - 2.5 fl oz tube)


Advanced Ingredient Data


Raw Label Data

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