Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID 08b28f52-21fc-4694-a163-91c8193b4008

Route

TOPICAL

Published

Effective Date 2025-05-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Allantoin (5 g) Benzethonium (1 g)

Inactive Ingredients

Water Alcohol Aloe Vera Whole Hydrastis Canadensis Whole Panax Quinquefolius Whole Hydrogen Peroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-05-17

Description

Allantoin 0.5%........................Skin Protectant Benzethonium Chloride 0.1%............Antiseptic

Purpose

Allantoin 0.5%........................Skin Protectant Benzethonium Chloride 0.1%............Antiseptic

Medication Information

Warnings and Precautions

Warnings For external use only.

Purpose

Allantoin 0.5%........................Skin Protectant Benzethonium Chloride 0.1%............Antiseptic

Description

Allantoin 0.5%........................Skin Protectant Benzethonium Chloride 0.1%............Antiseptic

Uses

helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips
topical antiseptic to help decrease the risk of skin infections

Section 50565-1

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

Section 51945-4

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

directions:

Adults and children 2 years of age and older:

use to clean minor cut, scrapes, and burns by thoroughly flushing the affected area
let air dry
cover with adhesive bandage or sterile gauze
apply a small amount of this product on the area 1 to 3 times daily

Children under 2 years of age: do not use, consult a doctor

inactive Ingredients:

Aloe barbadensis Mill, Ethanol, Hydrastis canadensis L., Hydrogen Peroxide, Panax quinquefolis L., Water

Active Ingredient/purpose

Allantoin 0.5%........................Skin Protectant

Benzethonium Chloride 0.1%............Antiseptic

Stop Use and Ask Doctor If

condition worsens
symptons persist for more than 7 days or clear up and occur again within a few days

Ask Doctor Before Use If You Have

deep or puncture wounds
animal bites
serious burns

Structured Label Content

Uses

helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips
topical antiseptic to help decrease the risk of skin infections

Warnings and Precautions (34071-1)

Warnings For external use only.

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Do Not Use (Do not use )

in large quantities, particularly over raw surfaces or blistered areas

directions: (Directions:)

Adults and children 2 years of age and older:

use to clean minor cut, scrapes, and burns by thoroughly flushing the affected area
let air dry
cover with adhesive bandage or sterile gauze
apply a small amount of this product on the area 1 to 3 times daily

Children under 2 years of age: do not use, consult a doctor

inactive Ingredients: (Inactive ingredients:)

Aloe barbadensis Mill, Ethanol, Hydrastis canadensis L., Hydrogen Peroxide, Panax quinquefolis L., Water

Active Ingredient/purpose (Active Ingredient/Purpose)

Allantoin 0.5%........................Skin Protectant

Benzethonium Chloride 0.1%............Antiseptic

Stop Use and Ask Doctor If (Stop use and ask doctor if)

condition worsens
symptons persist for more than 7 days or clear up and occur again within a few days

Ask Doctor Before Use If You Have (Ask doctor before use if you have)

deep or puncture wounds
animal bites
serious burns

Advanced Ingredient Data

[{"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1000", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZETHONIUM", "unii": "1VU15B70BP", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1000", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA WHOLE", "unii": "KIZ4X2EHYX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRASTIS CANADENSIS WHOLE", "unii": "R763EBH88T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANAX QUINQUEFOLIUS WHOLE", "unii": "0P067WOA1X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "hydrogen peroxide", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips topical antiseptic to help decrease the risk of skin infections", "34071-1": "Warnings For external use only.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately", "Do not use ": "in large quantities, particularly over raw surfaces or blistered areas", "Directions:": "Adults and children 2 years of age and older: use to clean minor cut, scrapes, and burns by thoroughly flushing the affected area let air dry cover with adhesive bandage or sterile gauze apply a small amount of this product on the area 1 to 3 times daily Children under 2 years of age: do not use, consult a doctor", "Inactive ingredients:": "Aloe barbadensis Mill, Ethanol, Hydrastis canadensis L., Hydrogen Peroxide, Panax quinquefolis L., Water", "Active Ingredient/Purpose": "Allantoin 0.5%........................Skin Protectant Benzethonium Chloride 0.1%............Antiseptic", "Stop use and ask doctor if": "condition worsens symptons persist for more than 7 days or clear up and occur again within a few days", "Ask doctor before use if you have": "deep or puncture wounds animal bites serious burns"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:12.251364 · Updated: 2026-03-14T23:08:50.768383