Elta Dermavase

Dosage form: cream
Ingredients: Zinc Oxide 75g in 1000g
Labeler: Swiss-American Products
NDC Code: 60232-8581

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.

Elta Dermavase

Active Ingredient Purpose
Zinc Oxide 7.5%.............Skin Protectant

Uses- For temporary protection and lubrication of skin irritations, chafing and rubbing
- Waterproof barrier protects skin against moisture from incontinence and from trauma in skin folds causes by skin-to-skin contact
- Safe for all skin types

Warnings
For external use only. Avoid contact with eyes. Stop use and contact doctor
if condition worsens or symptoms last more than 7 days. Keep out of reach of children. If swallowed get medical help and contact a Poison Control Center immediately. For children under 2, consult doctor.

Directions
- Apply as often as necessary for incontinence, abraded skin, irritated areas and minor wounds
- Apply directly to affected area
- Reapply at least every 12 hours

Inactive Ingredients
Bees wax, hydrogenated castor oil, cetyl dimethicone, cetyl dimethicone copolyol (and) polyglyceryl-4 isostearate (and) hexyl laurate, disodium EDTA, isopropyl myristate, isopropyl palmitate, methylparaben, paraffin, petrolatum, sodium chloride, propylene glycol, propylparaben, water.

ELTA DERMAVASE  
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-8581
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide75 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
Water 
Methylparaben 
Propylparaben 
Propylene Glycol 
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) 
Sodium Hydroxide 
Citric Acid Monohydrate 
Disodium EDTA-copper 
Sodium Chloride 
Sodium Bisulfite 
Papain 
BROMELAINS 
Dimethicone 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) 
Isopropyl Palmitate 
petrolatum 
Hexyl Laurate 
yellow wax 
Hydrogenated Castor Oil 
.ALPHA.-TOCOPHEROL 
ORANGE OIL 
Ergocalciferol 
FIG 
PEG-10 DIMETHICONE (600 CST) 
Polyglyceryl-4 Isostearate 
Butylene Glycol 
Phenoxyethanol 
Biotin 
Amino Acids 
Glutamine 
IODOPROPYNYL BUTYLCARBAMATE 
Proline 
Packaging
#Item CodePackage Description
1NDC:60232-8581-5142 g in 1 TUBE
2NDC:60232-8581-259 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/30/2009
Labeler - Swiss-American Products (611921669)
Registrant - Swiss-American Products (611921669)
Establishment
NameAddressID/FEIOperations
Swiss-American Products611921669manufacture

Revised: 06/2009
 
Swiss-American Products

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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