SBS 40 MEDICATED CREAM- allantoin cream

SBS 40 Medicated Cream by

Drug Labeling and Warnings

SBS 40 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

AQUA (WATER), CETYL ESTERS, PETROLATUM, ISOPROPYL PALMITATE, STEARYL ALCOHOL, CARBOMER, CETEARETH-20, CHLOROXYLENOL, METHYLPARABEN, LANOLIN, SODIUM HYDROXIDE, PROPYLPARABEN, PARFUM (FRAGRANCE).

PRINCIPAL DISPLAY PANEL

deb stoko

SBS-40

Medicated Skin Cream

Normal Skin

Crema medicada para la piel

Piel normal

EN Skin conditioning cream. Ideal for irritated skin.

Non-greasy. Non-irritating.

ES Acondicionador para la piel. Ideal para la piel

irritada. No es grasiento. No es irritante.

100 ml (3.38 fl oz)

Stock #:

SBS100ML

DCN8807/0115

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com Made in USA

INGREDIENTS AND APPEARANCE

SBS 40 MEDICATED CREAM 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-241
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)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CARBOMER 934 (UNII: Z135WT9208)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
LANOLIN (UNII: 7EV65EAW6H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-241-08	2500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2013
2	NDC: 11084-241-35	148 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2013	04/01/2018
3	NDC: 11084-241-39	30 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2013
4	NDC: 11084-241-10	100 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2015

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(11084-241)