alocane ®

alocane ®
SPL v7
SPL
SPL Set ID fe58bb89-7216-4121-afd3-d1438bdfbfa2
Route
topical
Published
Effective Date 2022-06-03
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 chlorphenesin caprylyl glycol .alpha.-tocopherol acetate water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-02-13

Purpose

Topical Analgesic

Description

Drug Facts


Medication Information

Warnings

For external use only. Avoid contact with eyes.

Uses

For the temporary relief of pain and itching associated with:

  • Sunburn
  • Minor Bums
  • Minor Skin Irritation
  • Cuts & Scrapes
  • Insect Bites
Purpose

Topical Analgesic

Other Information

Store at room temperature 15-30ºC (59-86ºF)

Inactive Ingredients

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

Description

Drug Facts

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.

Active Ingredient

Lidocaine HCL 4%

Principal Display Panel 10 Pad Box

Adults and Children 2 Years of Age Or Older
  • Clean the burn area with mild soap and water.
  • Gently apply the Alocane• Pad over the burn or wound.
  • Use on affected area not more than 3 to 4 times daily
  • Children under 2 years of age consult a doctor.

Structured Label Content

Warnings

For external use only. Avoid contact with eyes.

Uses

For the temporary relief of pain and itching associated with:

  • Sunburn
  • Minor Bums
  • Minor Skin Irritation
  • Cuts & Scrapes
  • Insect Bites
Purpose

Topical Analgesic

Other Information

Store at room temperature 15-30ºC (59-86ºF)

Inactive Ingredients

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

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.

Active Ingredient

Lidocaine HCL 4%

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

Adults and Children 2 Years of Age Or Older (Adults and children 2 years of age or older)
  • Clean the burn area with mild soap and water.
  • Gently apply the Alocane• Pad over the burn or wound.
  • Use on affected area not more than 3 to 4 times daily
  • Children under 2 years of age consult a doctor.

Advanced Ingredient Data


Raw Label Data

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