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SBS 41 Medicated Cream

Medically reviewed on October 9, 2017

Dosage form: cream
Ingredients: ALLANTOIN 5mg in 1mL
Labeler: Deb USA, Inc.
NDC Code: 11084-141

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

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, Phenoxyethanol, Stearyl Alcohol, Diazolidinyl Urea, Ceteareth-20, Carbomer, PEG-75 Lanolin, Hydroxyethylcellulose, Ethanolamine, Fragrance

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

1 Liter

33.8 Fluid Ounces

40127

USDA Certified Biobased Product

Made in USA

Deb USA, Inc.

Charlotte, NC 28217-1388

1-800-248-7190

www.debgroup.com

Rev. 08-13

SBS 41 MEDICATED CREAM 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-141
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CETYL ESTERS WAX 
PETROLATUM 
ISOPROPYL PALMITATE 
PHENOXYETHANOL 
DIAZOLIDINYL UREA 
CARBOMER 934 
PEG-75 LANOLIN 
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) 
POLYOXYL 20 CETOSTEARYL ETHER 
MONOETHANOLAMINE 
Packaging
#Item CodePackage Description
1NDC:11084-141-271000 mL in 1 BOTTLE
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.078805627manufacture(11084-141)

 
Deb USA, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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