SBS 41 MEDICATED CREAM- allantoin cream

SBS 41 Medicated Cream by

Drug Labeling and Warnings

SBS 41 Medicated Cream by is a Otc medication manufactured, distributed, or labeled by SC Johnson Professional 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, Diazolidinyl Urea, Ceteareth-20, Carbomer, PEG-75 Lanolin, Hydroxyethylcellulose, Ethanolamine, Fragrance

PRINCIPAL DISPLAY PANEL

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

1 Liter

33.8 Fluid Ounces

40127

USDA Certified Biobased Product

Made in USA

Deb USA, Inc.

Charlotte, NC 28217-1388

1-800-248-7190

www.debgroup.com

Rev. 08-13

INGREDIENTS AND APPEARANCE

SBS 41 MEDICATED CREAM 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
CARBOMER 934 (UNII: Z135WT9208)
PEG-75 LANOLIN (UNII: 09179OX7TB)
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) (UNII: ZYD53NBL45)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
MONOETHANOLAMINE (UNII: 5KV86114PT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-141-27	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/01/2013

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		078805627	manufacture(11084-141)