Elta Provase

Dosage form: cream
Ingredients: Dimethicone 20g in 1000g
Labeler: Swiss-American Products
NDC Code: 60232-8573

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 Provase

Active Ingredient Purpose

Dimethicone 2%..........................Skin Protectant

INDICATION:

Elta Provase penetrates quickly for rapid relief of itching associated with dry or irritated skin.
This very light, 'dry to the touch' formula delivers Provase Cream enzymes to the skin to help remodel epidermal skin layers.

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. For children under 2, consult doctor. If swallowed, get medical help and contact a Poison Control Center immediately. Do not use on deep puncture wounds, infections, lacerations or animal bites.

Uses- Temporarily protects and relieves skin irritation and itching due to:
-Rashes -Eczema
- Helps relieve itching, scaling, irritation, redness and discomfort
- Temporarily protects and helps relieve chapped or cracked skin

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control

Directions- Cleanse affected area and allow to dry
- Apply liberally as often as needed

Inactive Ingredients
beeswax, biotin, bromelain, cetyl dimethicone, cetyl PEG/PPG/10/1 dimethicone, citric acid, cyclomethicone, dimethicone, disodium EDTA, ficin, fragrance, glutamine, hexyl laurate, hydrogenated castor oil, isopropyl palmitate, methylparaben, octyl stearate, papain, paraffin, petrolatum, polyglyceryl-4 isostearate, proline, propylene glycol, propylparaben, purified water, sodium bisulfite, sodium chloride, sodium hydroxide

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ELTA PROVASE  
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-8573
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone20 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
Water 
Sodium Hydroxide 
Citric Acid Monohydrate 
DISODIUM EDTA-COPPER 
Sodium Chloride 
Methylparaben 
Propylparaben 
Propylene Glycol 
Sodium Bisulfite 
Papain 
BROMELAINS 
Petrolatum 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) 
Isopropyl Palmitate 
Octyl Stearate 
Hexyl Laurate 
PARAFFIN 
YELLOW WAX 
Hydrogenated Castor Oil 
Eucalyptus Oil 
CYCLOMETHICONE 
VANILLA 
FIG 
PEG-10 DIMETHICONE (600 CST) 
Polyglyceryl-4 Isostearate 
Biotin 
Amino Acids 
Packaging
#Item CodePackage Description
1NDC:60232-8573-359 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34704/30/2002
Labeler - Swiss-American Products (611921669)
Registrant - Swiss-American Products (611921669)
Establishment
NameAddressID/FEIOperations
Swiss-American Products611921669manufacture

Revised: 07/2009
 
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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