SBS 40 Medicated Cream

Dosage form: cream
Ingredients: ALLANTOIN 5mg in 100mL
Labeler: Deb USA, Inc.
NDC Code: 11084-241

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.

SBS 40 Medicated Cream

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, Stearyl Alcohol, Carbomer, Ceteareth-20, Chloroxylenol, Methylparaben, Lanolin,
Sodium Hydroxide, Proplparaben, Fragrance

deb

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

2.5 Liter

85 Fluid Ounces

USDA Certified Biobased Product

Made in USA

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com

40108

Rev. 09-13

SBS 40 MEDICATED CREAM 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-241
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER 934 
CETYL ESTERS WAX 
PETROLATUM 
ISOPROPYL PALMITATE 
LANOLIN 
TRIETHANOLAMINE BENZOATE 
DIAZOLIDINYL UREA 
PHENOXYETHANOL 
POLYOXYL 20 CETOSTEARYL ETHER 
Packaging
#Item CodePackage Description
1NDC:11084-241-082500 mL in 1 BOTTLE
2NDC:11084-241-35148 mL in 1 TUBE
3NDC:11084-241-3930 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/01/2013
Labeler - Deb USA, Inc. (607378015)
Establishment
NameAddressID/FEIOperations
Deb USA, Inc.607378015manufacture(11084-241)

Revised: 10/2013
 
Deb USA, Inc.

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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