Medication Guide App

SBS Care

Dosage form: lotion
Ingredients: Allantoin 0.5mL in 100mL
Labeler: Deb USA, Inc.
NDC Code: 11084-089

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

Soothes and softens dry, chapped skin

Medicated formulation helps heal minor cuts or scrapes

Alleviates the skin rashes, irritation and itching associated with dermatitis

Warnings

For external use only

Avoid contact with the eyes

Keep out of the reach of children

Consult with a physician if ingested

Directions

Apply SBS Care to clean hands

Rub in well

Re-apply after handwashing or as needed

Water, Cetyl Esters, Petrolatum, Isopropyl Palmtate, Stearyl Alcohol, Carbomer, Triethanolamine, Ceteareth-20, Chloroxylenol, Lanolin, Methylparaben, Simmondsia Chinensis (Jojoba) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Fragrance, Aloe Barbadensis Leaf Juice, Propylparaben.

SBS Care

Medicated Skin Cream

Restore

1 fluid ounce

30 milliliters

Deb

89139-06-093

Proudly made in the USA by Deb

SBS CARE 
allantoin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-089
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (Allantoin) Allantoin0.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Cetyl Esters Wax 
Petrolatum 
Isopropyl Palmitate 
Carbomer 934 
Trolamine 
Chloroxylenol 
Lanolin 
Methylparaben 
Jojoba Oil 
Wheat Germ Oil 
Aloe 
Propylparaben 
Stearyl Alcohol 
Polyoxyl 20 Cetostearyl Ether 
Packaging
#Item CodePackage Description
1NDC:11084-089-35150 mL in 1 TUBE
2NDC:11084-089-3930 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: 11/2010
 
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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