SBS 40

Manufacturer: Deb USA, Inc.
Effective date: 2017-02-15
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-05-31 22:48:48

Label at a glance#

ProductSBS 40

Active ingredientALLANTOIN

Label structure7 sections

Indications and uses

Temporarily protects and helps relieve chapped or cracked skin Helps protect from the drying effects of wind and cold weather

Dosage and administration

apply to clean, dry hands as needed rub in well

Contacts and useful links#

PhoneLabel contact1-800-248-7190

Websitewww.debgroup.com

www.debgroup.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Allantoin, 0.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

deep or puncture wounds

animal bites

serious burns

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes.

In case of eye contact, flush with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or sensitivity develops

condition worsens

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

apply to clean, dry hands as needed

rub in well

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product label

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
241509	allantoin 0.5 % Topical Cream	PSN	10
241509	allantoin 5 MG/ML Topical Cream	SCD	10
241509	allantoin 0.5 % Topical Cream	SY	10

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11084-240-08	2020-01-31	C162847	48780-1	9d75b9d0-55c9-f424-e053-dadaa90a57ce	SBS 40
11084-240-35	2020-01-31	C162847	48780-1	9d75b9d0-55c9-f424-e053-dadaa90a57ce	SBS 40
11084-240-39	2020-01-31	C162847	48780-1	9d75b9d0-55c9-f424-e053-dadaa90a57ce	SBS 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11084-240-08	SBS 40	2500 mL in 1 BOTTLE	CREAM	2500	10
11084-240-35	SBS 40	148 mL in 1 TUBE	CREAM	148	10
11084-240-39	SBS 40	30 mL in 1 TUBE	CREAM	30	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11084-240	SBS 40 (ALLANTOIN) CREAM [DEB USA, INC.]	10	Legacy NDC, 3 package rows	20170215_08e8ecd8-1ea0-4d84-9790-55d73bf0eb07.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ALLANTOIN	ACTIVE INGREDIENT	344S277G0Z	9
ALLANTOIN	ACTIVE MOIETY	344S277G0Z	9
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	9
CETYL ESTERS WAX	INACTIVE INGREDIENT	D072FFP9GU	9
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	9
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	9
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	9
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	9
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	9
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	9
TRIETHANOLAMINE BENZOATE	INACTIVE INGREDIENT	M3EN4GC19W	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	9

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

SBS 40
Allantoin
WATER
CARBOMER 934
CETYL ESTERS WAX
PETROLATUM
ISOPROPYL PALMITATE
LANOLIN
TRIETHANOLAMINE BENZOATE
DIAZOLIDINYL UREA
PHENOXYETHANOL
POLYOXYL 20 CETOSTEARYL ETHER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11084-240	11084-240-08, 11084-240-35, 11084-240-39

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALLANTOIN	344S277G0Z	ACTIB
WATER	059QF0KO0R	IACT
CARBOMER 934	Z135WT9208	IACT
CETYL ESTERS WAX	D072FFP9GU	IACT
PETROLATUM	4T6H12BN9U	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
LANOLIN	7EV65EAW6H	IACT
TRIETHANOLAMINE BENZOATE	M3EN4GC19W	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 70 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SUSPENSION / OPHTHALMIC	0.45 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	AEROSOL / TOPICAL	5.5 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	CREAM / TOPICAL		180 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	AEROSOL, FOAM / TOPICAL		374 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
CETYL ESTERS WAX	CETYL ESTERS WAX	D072FFP9GU	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	GEL / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	GEL / TOPICAL		30 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	CREAM / TOPICAL		600 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SUSPENSION/ DROPS / OPHTHALMIC	0.4 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
CETYL ESTERS WAX	CETYL ESTERS WAX	D072FFP9GU	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	CAPSULE / ORAL		32 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	LOTION / TOPICAL		71 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SUSPENSION / ORAL		288 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CETYL ESTERS WAX	CETYL ESTERS WAX	D072FFP9GU	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL, SPRAY / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	GEL, METERED / TRANSDERMAL	1 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	ENEMA / RECTAL	0.24 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CETYL ESTERS WAX	CETYL ESTERS WAX	D072FFP9GU	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	OINTMENT / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	LOTION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	SUSPENSION / ORAL		20 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM / TRANSDERMAL		2 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
CETYL ESTERS WAX	CETYL ESTERS WAX	D072FFP9GU	CREAM / TOPICAL	10.3 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d12f476d-35fd-4e9b-a4d7-ad5d26c98b90			08e8ecd8-1ea0-4d84-9790-55d73bf0eb07	2017-02-15	Warnings	Exact identifier spl id: d12f476d-35fd-4e9b-a4d7-ad5d26c98b90 spl set id: 08e8ecd8-1ea0-4d84-9790-55d73bf0eb07

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.