SBS 40 by Deb USA, Inc. SBS 40- allantoin cream

SBS 40 by

Drug Labeling and Warnings

SBS 40 by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Allantoin, 0.5%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Warnings

For external use only

Do not use on

deep or puncture wounds

animal bites

serious burns

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

Keep out of reach of children

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

SBS 40 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LANOLIN (UNII: 7EV65EAW6H)
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-240-08	2500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2013	03/01/2017
2	NDC: 11084-240-35	148 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2013	03/01/2017
3	NDC: 11084-240-39	30 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2013	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2013

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		078805627	manufacture(11084-240)