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SBS 40 by Deb USA, Inc.

Dosage form: lotion
Ingredients: Allantoin 0.5mL in 100 mL
Labeler: Deb USA, Inc.
NDC Code: 11084-040

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.

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

SBS 40 
allantoin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (Allantoin) Allantoin0.5 mL  in 100  mL
Inactive Ingredients
Ingredient NameStrength
Cetyl Esters Wax 
Petrolatum 
Isopropyl Palmitate 
Carbomer 934 
Trolamine 
Chloroxylenol 
Methylparaben 
Lanolin 
Propylparaben 
Stearyl Alcohol 
POLYOXYL 20 CETOSTEARYL ETHER 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
MAGNESIUM NITRATE 
MAGNESIUM CHLORIDE 
Water 
Packaging
#Item CodePackage Description
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/FEIOperations
Deb USA, Inc.607378015manufacture

Revised: 09/2010
 
Deb USA, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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