Alocane ®

Alocane ®
SPL v2
SPL
SPL Set ID 0a35ac19-6883-a733-e063-6294a90ad22d
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
Propanediol Aloe Vera Leaf Dimethyl Isosorbide Hydroxyethyl Cellulose (5500 Mpa.s At 2%) Phenoxyethanol Caprylyl Glycol Chlorphenesin .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-15

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses:

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

  • Burns
  • Cuts
  • Sunburn
  • Scrapes
  • Minor Skin Irritations
Section 42229-5

Drug Facts

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.

Section 55105-1
Active Ingredient Purpose

Benzalkonium Chloride 0.13%

Lidocaine HCL 4%

First Aid Antiseptic

Topical Analgesic

Warnings

For External Use Only.

Directions

Adults and children 2 years of age and older: Clean affected area and let dry. Gently apply the Burn Pad over the burn or wound. Cover with adhesive tape or stretch gauze. Use on affected area not more than 3 or 4 times daily.

Children under 2 years of age: ask a doctor.

Other Information

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

Inactive Ingredients

1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Water.

Principal Display Panel 10 Pad Carton


Structured Label Content

Uses:

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

  • Burns
  • Cuts
  • Sunburn
  • Scrapes
  • Minor Skin Irritations
Section 42229-5 (42229-5)

Drug Facts

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.

Section 55105-1 (55105-1)
Active Ingredient Purpose

Benzalkonium Chloride 0.13%

Lidocaine HCL 4%

First Aid Antiseptic

Topical Analgesic

Warnings

For External Use Only.

Directions

Adults and children 2 years of age and older: Clean affected area and let dry. Gently apply the Burn Pad over the burn or wound. Cover with adhesive tape or stretch gauze. Use on affected area not more than 3 or 4 times daily.

Children under 2 years of age: ask a doctor.

Other Information

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

Inactive Ingredients

1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Water.

Principal Display Panel 10 Pad Carton (PRINCIPAL DISPLAY PANEL - 10 Pad Carton)


Advanced Ingredient Data


Raw Label Data

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