Alocane ®

Alocane ®
SPL v10
SPL
SPL Set ID 24538037-1d74-48a0-b909-98ecc57651fe
Route
TOPICAL
Published
Effective Date 2022-06-22
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 Completed Since 2013-12-11 Until 2025-07-15

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

For the temporary relief of pain and itching associated with: Sunburn, Minor Cuts & Scrapes, Minor Skin Irritation, Minor Burns

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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.

Section 55105-1
Active Ingredient Purpose
Lidocaine HCL 4% Topical Analgesic
Benzalkonium Chloride 0.13% Topical Antiseptic
Warnings

For external use only. Avoid contact with eyes.

Directions

Apply to affected area not more than 3 to 4 times daily. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Children under 2 years of age, consult a physician.

Other Information

Store at Room Temperature of 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 59 Ml Tube Carton


Structured Label Content

Uses

For the temporary relief of pain and itching associated with: Sunburn, Minor Cuts & Scrapes, Minor Skin Irritation, Minor Burns

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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.

Section 55105-1 (55105-1)
Active Ingredient Purpose
Lidocaine HCL 4% Topical Analgesic
Benzalkonium Chloride 0.13% Topical Antiseptic
Warnings

For external use only. Avoid contact with eyes.

Directions

Apply to affected area not more than 3 to 4 times daily. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Children under 2 years of age, consult a physician.

Other Information

Store at Room Temperature of 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 59 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton)


Advanced Ingredient Data


Raw Label Data

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