SBS 40 - allantoin lotion 
Deb 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


When using this product do not get in eyes

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

Enter section text here

Keep out of the reach of children

Directions

Apply SBS-40 as needed

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.

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

SBS 40 
allantoin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin0.5 mL  in 100  mL
Inactive Ingredients
Ingredient NameStrength
Cetyl Esters Wax (UNII: D072FFP9GU)  
Petrolatum (UNII: 4T6H12BN9U)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Carbomer 934 (UNII: Z135WT9208)  
Trolamine (UNII: 9O3K93S3TK)  
Chloroxylenol (UNII: 0F32U78V2Q)  
Methylparaben (UNII: A2I8C7HI9T)  
Lanolin (UNII: 7EV65EAW6H)  
Propylparaben (UNII: Z8IX2SC1OH)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11084-040-082500 mL in 1 BOTTLE, PLASTIC
2NDC:11084-040-35148 mL in 1 TUBE
3NDC:11084-040-3930 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2010
Labeler - Deb USA, Inc. (607378015)
Establishment
NameAddressID/FEIBusiness Operations
Deb USA, Inc.607378015manufacture

Revised: 9/2010
Document Id: a6650b96-9a5e-43e6-8bd4-a8d6d4c74815
Set id: 52b86b15-5df4-4042-ac2b-b96fbd3db0a7
Version: 1
Effective Time: 20100903
 
Deb USA, Inc.