SBS 40 MEDICATED CREAM- allantoin cream
SC Johnson Professional USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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).

SBS100ML-SBS-40 Medicated Skin Cream-V5b.jpg

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

SBS 40 MEDICATED CREAM
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-241
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11084-241-08	2500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2013	06/30/2021
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	01/28/2023
4	NDC:11084-241-10	100 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2015	02/03/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/01/2013	12/31/2023

Labeler - SC Johnson Professional USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
SC Johnson Professional USA, Inc.		078805627	manufacture(11084-241)

Revised: 12/2020

Document Id: b58469b3-6317-4430-8d4b-67f416a98d85

Set id: 74b70afd-82f1-4fd0-8673-431d9f87b35c

Version: 11

Effective Time: 20201202

SC Johnson Professional USA, Inc.