Alocane ®

Alocane ®
SPL v14
SPL
SPL Set ID 0c8e65a6-dff3-43b4-a3f1-95deb574ea89
Route
TOPICAL
Published
Effective Date 2021-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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 2019-03-01 Until 2022-09-30

Description

Drug Facts

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Dosage and Administration

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Description

Drug Facts

Uses

For the temporary relief of pain and itching associated with:

  • Sunburn
  • Minor Skin Irritation
  • Minor Burns
  • Cuts & Scrapes
  • Insect Bites
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.

Section 53414-9

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

Warnings

For external use only. Avoid contact with eyes.

Directions:

Adults and Children 2 years of age or older:

  • Clean the burn area with mild soap and water
  • Gently apply over bthe burn or wound
  • Use on affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

Active Ingredient

Lidocaine HCL 4%

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 Alocane Burn Gel Pump

Principal Display Panel Alocane Burn Spray 3.5 Fl Oz

Principal Display Panel Alocane Burn Gel 2.5 Fl Oz Tube

Principal Display Panel Alocane Burn Gel Single Use 45 Count


Structured Label Content

Uses

For the temporary relief of pain and itching associated with:

  • Sunburn
  • Minor Skin Irritation
  • Minor Burns
  • Cuts & Scrapes
  • Insect Bites
Dosage and Administration (34068-7)

Do not use in large quantities, particularly over raw surfaces or blistered areas.

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.

Section 53414-9 (53414-9)

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

Purpose

Topical Analgesic

Warnings

For external use only. Avoid contact with eyes.

Directions:

Adults and Children 2 years of age or older:

  • Clean the burn area with mild soap and water
  • Gently apply over bthe burn or wound
  • Use on affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

Active Ingredient

Lidocaine HCL 4%

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 Alocane Burn Gel Pump (PRINCIPAL DISPLAY PANEL -- ALOCANE Burn Gel Pump)

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

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

Principal Display Panel Alocane Burn Gel Single Use 45 Count (PRINCIPAL DISPLAY PANEL - ALOCANE Burn Gel Single Use 45 Count)


Advanced Ingredient Data


Raw Label Data

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