Label: PREMIUM SCAR PATCH- allantoin, lidocaine, petrolatum patch
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Contains inactivated NDC Code(s)
NDC Code(s): 69512-020-01 - Packager: Alivio Medical Products, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 13, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DESCRIPTION
- DESCRIPTION
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Do not use
-on deep or puncture wounds, animal bites, serious burns
-in large quantities, particularly over raw surfaces or blistered areas
When using this product
-avoid contact with eyes
Stop use and ask a doctor if
-condition worsens symptoms last more than 7 days or clear up and occur again within a few days
- DESCRIPTION
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DOSAGE & ADMINISTRATION
Directions:
How to apply - clean and dry affected area -remove mesh from backing and apply to affected area
-use only one mesh at a time, and maximum of four mesh/day -leave mesh on affected area for up to
8 hours -do not use mesh for longer than 5 consecutive days -children under 12 should consult
physician prior to use
- STORAGE AND HANDLING
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREMIUM SCAR PATCH
allantoin, lidocaine, petrolatum patchProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69512-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 2 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 30 g in 100 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ONION (UNII: 492225Q21H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69512-020-01 15 in 1 BOX 1 15 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/15/2015 Labeler - Alivio Medical Products, LLC (079670828)