sbs 40 - DailyMed Details

sbs 40

SPL v10

SPL

SPL Set ID 08e8ecd8-1ea0-4d84-9790-55d73bf0eb07

Route

topical

Published

Effective Date 2017-02-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

allantoin (5 mg)

Inactive Ingredients

water carbomer 934 cetyl esters wax petrolatum isopropyl palmitate lanolin triethanolamine benzoate diazolidinyl urea phenoxyethanol polyoxyl 20 cetostearyl ether

Identifiers & Packaging

Marketing Status

otc monograph final completed Since 2013-01-01 Until 2017-03-01

Purpose

Skin Protectant

Description

Allantoin, 0.5%

Medication Information

Warnings

For external use only

Uses

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Purpose

Skin Protectant

Directions

apply to clean, dry hands as needed

rub in well

Inactive Ingredients

Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Phenoxyethanol, Stearyl Alcohol, Carbomer, Triethanolamine, Diazolidinyl Urea, Ceteareth-20, Lanolin, Fragrance

Description

Allantoin, 0.5%

Section 50565-1

Keep out of reach of children

Section 51945-4

deb

SBS 40

Medicated Skin Cream

Silicone-free

Non-irritating

Non-greasy formulation

Helps heal dry hard-working hands

Industry's preferred brand for over 50 years

2.5 Liter

85 Fluid Ounces

USDA Certified Biobased Product

Made in USA

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com

40108

Rev. 01-13

Do Not Use On

deep or puncture wounds

animal bites

serious burns

Active Ingredient

Allantoin, 0.5%

When Using This Product

avoid contact with eyes.

In case of eye contact, flush with water.

Stop Use and Ask A Doctor If

irritation or sensitivity develops

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Structured Label Content

Warnings

For external use only

Uses

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Purpose

Skin Protectant

Directions

apply to clean, dry hands as needed

rub in well

Inactive Ingredients (Inactive ingredients)

Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Phenoxyethanol, Stearyl Alcohol, Carbomer, Triethanolamine, Diazolidinyl Urea, Ceteareth-20, Lanolin, Fragrance

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51945-4 (51945-4)

deb

SBS 40

Medicated Skin Cream

Silicone-free

Non-irritating

Non-greasy formulation

Helps heal dry hard-working hands

Industry's preferred brand for over 50 years

2.5 Liter

85 Fluid Ounces

USDA Certified Biobased Product

Made in USA

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com

40108

Rev. 01-13

Do Not Use On (Do not use on)

deep or puncture wounds

animal bites

serious burns

Active Ingredient (Active ingredient)

Allantoin, 0.5%

When Using This Product (When using this product)

avoid contact with eyes.

In case of eye contact, flush with water.

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

irritation or sensitivity develops

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data

[{"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL ESTERS WAX", "unii": "D072FFP9GU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL PALMITATE", "unii": "8CRQ2TH63M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHANOLAMINE BENZOATE", "unii": "M3EN4GC19W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIAZOLIDINYL UREA", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 20 CETOSTEARYL ETHER", "unii": "YRC528SWUY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily protects and helps relieve chapped or cracked skin Helps protect from the drying effects of wind and cold weather", "50565-1": "Keep out of reach of children", "51945-4": "deb SBS 40 Medicated Skin Cream Silicone-free Non-irritating Non-greasy formulation Helps heal dry hard-working hands Industry's preferred brand for over 50 years 2.5 Liter 85 Fluid Ounces USDA Certified Biobased Product Made in USA Deb USA, Inc. Charlotte, NC 28217 1-800-248-7190 www.debgroup.com 40108 Rev. 01-13", "Purpose": "Skin Protectant", "Warnings": "For external use only", "Directions": "apply to clean, dry hands as needed rub in well", "Do not use on": "deep or puncture wounds animal bites serious burns", "Active ingredient": "Allantoin, 0.5%", "Inactive ingredients": "Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Phenoxyethanol, Stearyl Alcohol, Carbomer, Triethanolamine, Diazolidinyl Urea, Ceteareth-20, Lanolin, Fragrance", "When using this product": "avoid contact with eyes. In case of eye contact, flush with water.", "Stop use and ask a doctor if": "irritation or sensitivity develops condition worsens symptoms last more than 7 days or clear up and occur again within a few days"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:16.036512 · Updated: 2026-03-14T22:54:38.033285