Xilapak
Name: Xilapak
Xilapak KIT DESCRIPTION
Xilapak is supplied as 3 components in a kit:
- FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% (NDC 52565-012-59), 60mL - CETAPHIL CLEANSER (NDC 00299-3921-40), 4 fl oz - SILICONE TAPE, 1 Roll, 5.5 yards
Contraindications
Do not use if known hypersensitivity to any of the listed ingredients of any of the components included in the kit.
Product details
For All Skin Types
- Mild, non-irritating formula
- Softens as it cleans
- Non-comedogenic/fragrance free
- Dermatologist recommended
This gentle, soap-free cleanser was originally formulated for dermatologists, specifically for everyday cleansing of even the most sensitive skin.
- Soothing, non-irritating cleanser ideal for face, hands and body
- Helps skin retain needed moisture
- Rinses easily and leaves skin feeling soft, smooth and healthy
Ingredients: Water, Cetyl Alcohol, Propylene Glycol, Sodium Lauryl Sulfate, Stearyl Alcohol, Methylparaben, Propylparaben, Butylparaben
Cetaphil Cleanser is easy to use:
Directions for use with water: Apply cleanser and gently massage into skin. Rinse.
Directions for use without Water: Apply a liberal amount to the skin and rub gently. Remove excess with a soft cloth, leaving a thin film of CETAPHIL on the skin.
Side Effects
No common side effects have been reported with this product. Stop use and ask a doctor if rash occurs.
Silicone Tape, 1 Roll, 5.5 yards
Purpose
For alleviating tension on the scar and its surrounding skin. Tension on a wound and scar is known to increase scar tissue formation.
Because of its adherence, silicone tape reduces tension (e.g. tear and stretch) along the incision line or wound which is known to minimize the degree of scarring in terms of spreading or thickening.
PRINCIPAL DISPLAY PANEL - Kit Carton
Solutech
PHARMACEUTICALS
Xilapak KIT
NDC 70350-5218-1
RX ONLY
| Established Pharmacological Class |
| Substance | Pharmacological Class | | CETAPHIL CLEANSER | CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS) | |
Xilapak
fluocinolone acetonide kit |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:70350-5218 | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:70350-5218-1 | 1 KIT in 1 CARTON | |
| Quantity of Parts | | Part # | Package Quantity | Total Product Quantity | | Part 1 | 1 BOTTLE, WITH APPLICATOR | 60 mL | | Part 2 | 1 BOTTLE | 118 mL | |
| Part 1 of 2 | FLUOCINOLONE ACETONIDE
fluocinolone acetonide solution | |
| Product Information | | Item Code (Source) | NDC:52565-012 | | Route of Administration | TOPICAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) | FLUOCINOLONE ACETONIDE | 0.1 mg in 1 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | ANHYDROUS CITRIC ACID | | | PROPYLENE GLYCOL | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:52565-012-59 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON | | 1 | | 60 mL in 1 BOTTLE, WITH APPLICATOR | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA authorized generic | NDA015296 | 11/27/2012 | | |
| Part 2 of 2 | CETAPHIL CLEANSER
rinse | |
| Product Information | | Item Code (Source) | 0299-3921 | | Route of Administration | TOPICAL | DEA Schedule | | |
| Ingredients | | Ingredient Name | Quantity | | Water | | | CETYL ALCOHOL | | | PROPYLENE GLYCOL | | | SODIUM LAURYL SULFATE | | | STEARYL ALCOHOL | | | METHYLPARABEN | | | PROPYLPARABEN | | | BUTYLPARABEN | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | 0299-3921-40 | 118 mL in 1 BOTTLE | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Cosmetic | | | | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | NDA authorized generic | NDA015296 | 11/01/2017 | | |
| Labeler - SOLUTECH PHARMACEUTICALS LLC (080040396) |
Revised: 11/2017 SOLUTECH PHARMACEUTICALS LLC
