SBS 40

Manufacturer: Deb USA, Inc.
Effective date: 2010-09-03
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:25:46

Label at a glance#

ProductSBS 40

Active ingredientAllantoin

Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Allantoin, 0.5%

OTC - PURPOSE SECTION

Purpose

Skin protectant

INDICATIONS & USAGE SECTION

Uses

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product do not get in eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

conditions worsen

symptoms last more than 7 days

or clear up and occur again within a few days

OTC - DO NOT USE SECTION

Enter section text here

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

DOSAGE & ADMINISTRATION SECTION

Directions

Apply SBS-40 as needed

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Cetyl Esters, Petrolatum, Isopropyl Palmitate, Stearyl Alcohol, Carbomer, Triethanolamine, Ceteareth-20, Chloroxylenol, Methylparaben, Lanolin, Propylparaben, Fragrance, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

deb

SBS 40

Medicated Skin Cream

Skin Protectant

1-Protect

2-Cleanse

3-Restore

85 fl. oz. 2.5 liters

Made in U.S.A.

40108-05-026

Contains a blend of emollients including lanolin to keep skin soft and supple.

Recommended for professionals and individuals who have chapped or cracker hands.

Soothes and protects dry or chapped skin

container label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1087954	allantoin 0.5 % Topical Lotion	PSN	1
1087954	allantoin 5 MG/ML Topical Lotion	SCD	1
1087954	allantoin 0.5 % Topical Lotion	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11084-040-08	2019-10-21	C162847	48780-1	956f9ecf-c183-621f-e053-dbdaa90a74ad	Drug Facts
11084-040-35	2019-10-21	C162847	48780-1	956f9ecf-c183-621f-e053-dbdaa90a74ad	Drug Facts
11084-040-39	2019-10-21	C162847	48780-1	956f9ecf-c183-621f-e053-dbdaa90a74ad	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11084-040-08	SBS 40	2500 mL in 1 BOTTLE, PLASTIC	LOTION	2500	1
11084-040-35	SBS 40	148 mL in 1 TUBE	LOTION	148	1
11084-040-39	SBS 40	30 mL in 1 TUBE	LOTION	30	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11084-040	SBS 40 (ALLANTOIN) LOTION [DEB USA, INC.]	1	Legacy NDC, 3 package rows	20100908_52b86b15-5df4-4042-ac2b-b96fbd3db0a7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Allantoin	ACTIVE INGREDIENT	344S277G0Z	1
Allantoin	ACTIVE MOIETY	344S277G0Z	1
Carbomer 934	INACTIVE INGREDIENT	Z135WT9208	1
Cetyl Esters Wax	INACTIVE INGREDIENT	D072FFP9GU	1
Chloroxylenol	INACTIVE INGREDIENT	0F32U78V2Q	1
Isopropyl Palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	1
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	1
MAGNESIUM CHLORIDE	INACTIVE INGREDIENT	02F3473H9O	1
MAGNESIUM NITRATE	INACTIVE INGREDIENT	77CBG3UN78	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

SBS 40
Allantoin
Cetyl Esters Wax
Petrolatum
Isopropyl Palmitate
Carbomer 934
Trolamine
Chloroxylenol
Methylparaben
Lanolin
Propylparaben
Stearyl Alcohol
POLYOXYL 20 CETOSTEARYL ETHER
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
MAGNESIUM NITRATE
MAGNESIUM CHLORIDE
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11084-040	11084-040-08, 11084-040-35, 11084-040-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Allantoin	344S277G0Z	ACTIB
Cetyl Esters Wax	D072FFP9GU	IACT
Petrolatum	4T6H12BN9U	IACT
Isopropyl Palmitate	8CRQ2TH63M	IACT
Carbomer 934	Z135WT9208	IACT
Trolamine	9O3K93S3TK	IACT
Chloroxylenol	0F32U78V2Q	IACT
Methylparaben	A2I8C7HI9T	IACT
Lanolin	7EV65EAW6H	IACT
Propylparaben	Z8IX2SC1OH	IACT
Stearyl Alcohol	2KR89I4H1Y	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
METHYLCHLOROISOTHIAZOLINONE	DEL7T5QRPN	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
MAGNESIUM NITRATE	77CBG3UN78	IACT
MAGNESIUM CHLORIDE	02F3473H9O	IACT
Water	059QF0KO0R	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 5 · 251 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Lanolin	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SOLUTION / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 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
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	GEL / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SPRAY / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Carbomer 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SOLUTION / TOPICAL		10 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	TABLET, EXTENDED RELEASE / ORAL	244 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 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
Carbomer 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	EMULSION / TOPICAL		3405 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Chloroxylenol	CHLOROXYLENOL	0F32U78V2Q	CREAM / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Lanolin	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MAGNESIUM CHLORIDE	MAGNESIUM CHLORIDE	02F3473H9O	SUSPENSION / AURICULAR (OTIC)	0.06 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		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	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM, EXTENDED RELEASE / TRANSDERMAL	187.5 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Lanolin	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	POWDER / ORAL	0.11 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 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
a6650b96-9a5e-43e6-8bd4-a8d6d4c74815			52b86b15-5df4-4042-ac2b-b96fbd3db0a7	2010-09-03	Warnings	Exact identifier spl id: a6650b96-9a5e-43e6-8bd4-a8d6d4c74815 spl set id: 52b86b15-5df4-4042-ac2b-b96fbd3db0a7

Reported adverse events (FAERS/openFDA)#

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