NDC Code(s) : 70621-101-01, 70621-101-10, 70621-101-03, 70621-101-30, 70621-101-20
Packager : Biofrontera Inc.
Category : HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
| AMELUZaminolevulinic acid hydrochloride GEL | ||||||||||||||||||||||||||||||||||||||||
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| LABELER - Biofrontera Inc.(080213133) |
| REGISTRANT - Biofrontera Bioscience GmbH(344449645) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Glaropharm AG | 483257270 | MANUFACTURE(70621-101), PACK(70621-101), LABEL(70621-101) | |
PRINCIPAL DISPLAY PANEL
Outer Packaging, single Carton
NDC 70621-101-10
Ameluz® Rx Only
(aminolevulinic acid HCl) topical gel, 10%
Use contents within 3 months after opening. Discard after: __/ __/ __.
Store refrigerated 2°-8°C (36°-46°F), excursions permitted to 15°-30°C (59°-86°F).
Keep out of the sight and reach of children.
See package insert for dosage information. Net Wt. 2 g
Distributed By: Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Product of Switzerland
For Topical Use Only with BF-RhodoLED® or RhodoLED® XL lamp
Healthcare Professionals Only
Ingredients: Each gram of Ameluz Gel contains 100 mg of the active ingredient, aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid) and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglyceride, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water
Outer Packaging, Physician's Sample
NDC 70621-101-30
Ameluz® Rx Only
Physician's Sample
Not for sale
(aminolevulinic acid HCl) topical gel, 10%
Use contents within 3 months after opening. Discard after: __/ __/ __.
Store refrigerated 2°-8°C (36°-46°F), excursions permitted to 15°-30°C (59°-86°F).
Keep out of the sight and reach of children.
See package insert for dosage information. Net Wt. 2 g
Distributed By: Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Product of Switzerland
For Topical Use Only with BF-RhodoLED® lamp or RhodoLED® XL lamp
Healthcare Professionals Only
Ingredients: Each gram of Ameluz Gel contains 100 mg of the active ingredient, aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid) and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglyceride, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water
Outer Packaging, Multipack
10 tubes with Net Wt. 2g each NDC 70621-101-20
Ameluz® Rx Only
(aminolevulinic acid HCl) topical gel, 10%
For Topical Use Only with BF-RhodoLED® lamp or RhodoLED® XL lamp
Healthcare Professionals Only
See package insert for dosage information.
Distributed By: Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Product of Switzerland
10 tubes with Net Wt. 2g each NDC 70621-101-20
Ameluz® Rx Only
(aminolevulinic acid HCl) topical gel, 10%
Use contents within 3 months after opening the individual tube.
Place the enclosed Discard after: __/ __/ __.tag on tube once opened.
Store refrigerated 2°-8°C (36°-46°F), excursions permitted to 15°-30°C (59°-86°F).
Keep out of the sight and reach of children.
See package insert for dosage information.
Ingredients:
Each gram of Ameluz Gel contains 100 mg of the active ingredient, aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid) and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglyceride, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water
Distributed By: Biofrontera Inc.
120 Presidential Way, Suite 330
Woburn, MA 01801
Product of Switzerland
