Alocane ®

Alocane ®
SPL v4
SPL
SPL Set ID cfe8114b-df65-064b-e053-2a95a90a33f6
Route
TOPICAL
Published
Effective Date 2022-11-08
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 2021-12-03

Description

Drug Facts

Purpose

First Aid Antiseptic Topical Analgesic


Medication Information

Purpose

First Aid Antiseptic

Topical Analgesic

Description

Drug Facts

Uses

First Aid to help prevent bacterial infection associated with contamination of the skin. Temporarily relieves pain and itching due to:

  • minor cuts
  • scrapes
  • minor burns
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, get medical help or contact 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.

Warnings

For external use only. Avoid contact with eyes.

Directions:

Adults and children 2 years of age or older:

  • Shake well
  • Clean the affected area
  • Spray on the affected area 1 to 3 times daily
  • May be covered with a sterile bandage after drying

Children under 2 years of age: consult a doctor

Do Not Use:

in large quantities, particularly over raw surfaces or blistered areas.

Other Information

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

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 4.0%

Inactive Ingredients

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

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.

If Pregnant Or Breast Feeding

ask a health care professional before use.

Principal Display Panel 3.5 Fl Oz Spray


Structured Label Content

Uses

First Aid to help prevent bacterial infection associated with contamination of the skin. Temporarily relieves pain and itching due to:

  • minor cuts
  • scrapes
  • minor burns
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, get medical help or contact 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.

Purpose

First Aid Antiseptic

Topical Analgesic

Warnings

For external use only. Avoid contact with eyes.

Directions:

Adults and children 2 years of age or older:

  • Shake well
  • Clean the affected area
  • Spray on the affected area 1 to 3 times daily
  • May be covered with a sterile bandage after drying

Children under 2 years of age: consult a doctor

Do Not Use: (Do not use:)

in large quantities, particularly over raw surfaces or blistered areas.

Other Information

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

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 4.0%

Inactive Ingredients

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

Stop Use and Ask Doctor (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.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health care professional before use.

Principal Display Panel 3.5 Fl Oz Spray (PRINCIPAL DISPLAY PANEL - 3.5 fl oz Spray)


Advanced Ingredient Data


Raw Label Data

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