Alocane ®

Alocane ®
SPL v2
SPL
SPL Set ID 02a8e5c7-56f4-eb0d-e063-6294a90a80cd
Route
TOPICAL
Published
Effective Date 2023-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Mannitol Sodium Hydroxide Dexpanthenol Limosilactobacillus Fermentum Hyaluronate Sodium Glycerin Echinacea Purpurea Root Aloe Vera Leaf Hydroxyethyl Cellulose (5500 Mpa.s At 2%) Phenoxyethanol Water Calendula Officinalis Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-11

Description

Drug Facts

Purpose

Topical Pain Relief


Medication Information

Purpose

Topical Pain Relief

Description

Drug Facts

Uses

For the temporary relief of pain and itching associated with:

  • Sunburn
  • Minor Skin Irritation
  • Minor Burns
  • Minor Cuts & Scrapes
  • Insect Bites
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask doctor:

  • if condition worsens
  • 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 a severe burn or deep cut, broken or compromised skin

Section 50570-1

Do not use:

  • in large quantities, or over large areas of the body
  • Over raw surfaces or blistered areas
  • If you have an allergy to any of the ingredients
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:

Shake well. Apply top affected area not more than 3-4 times daily. To apply to face, spray on palm and carefully apply.

Children under 2 years of age, ask a doctor before use.

Active Ingredient

Lidocaine HCL 4%

Other Information

Store at 15-30°C (59-86°F)

Inactive Ingredients

Water, Phenoxyethanol, Aloe Vera Leaf Juice, Lactobacilus Ferment, Echinacea Purpurea Root Extract, Calendula Officinalis Flower Extract, Sodium Hyaluronate, D-Panthenol, Glycerin, Hydroxyethyl Cellulose, Mannitol, Sodium Hydroxide

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Structured Label Content

Uses

For the temporary relief of pain and itching associated with:

  • Sunburn
  • Minor Skin Irritation
  • Minor Burns
  • Minor Cuts & Scrapes
  • Insect Bites
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor:

  • if condition worsens
  • 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 a severe burn or deep cut, broken or compromised skin

Section 50570-1 (50570-1)

Do not use:

  • in large quantities, or over large areas of the body
  • Over raw surfaces or blistered areas
  • If you have an allergy to any of the ingredients
Section 53414-9 (53414-9)

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

Purpose

Topical Pain Relief

Warnings

For external use only. Avoid contact with eyes.

Directions:

Adults and Children 2 years of age or older:

Shake well. Apply top affected area not more than 3-4 times daily. To apply to face, spray on palm and carefully apply.

Children under 2 years of age, ask a doctor before use.

Active Ingredient

Lidocaine HCL 4%

Other Information

Store at 15-30°C (59-86°F)

Inactive Ingredients

Water, Phenoxyethanol, Aloe Vera Leaf Juice, Lactobacilus Ferment, Echinacea Purpurea Root Extract, Calendula Officinalis Flower Extract, Sodium Hyaluronate, D-Panthenol, Glycerin, Hydroxyethyl Cellulose, Mannitol, Sodium Hydroxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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