NDC | 59469-066-30, 59469-066-35 |
Set ID | 55786d99-ee1f-490f-9023-3e6c39da86b0 |
Category | HUMAN OTC DRUG LABEL |
Packager | PEKANA Naturheilmittel GmbH |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses1
- 1
- Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. These "Uses" have not been evaluated by the Food and Drug Administration. With severe forms of this disease, a clinically proven therapy is indicated.
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Warnings
For external use only. Do not use on open wounds! If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 35 g Tube Box
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INGREDIENTS AND APPEARANCE
KELAN
silicon dioxide, arnica montana root, graphite, hypericum perforatum, ledum palustre twig, magnesium fluoride, magnesium sulfate heptahydrate, and ruta graveolens flowering top ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59469-066 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide 6 [hp_X] in 35 g Arnica montana Root (UNII: MUE8Y11327) (Arnica montana Root - UNII:MUE8Y11327) Arnica montana Root 12 [hp_X] in 35 g Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite 6 [hp_X] in 35 g Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum 6 [hp_X] in 35 g RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG 12 [hp_X] in 35 g Magnesium fluoride (UNII: 5N014C7IWU) (Magnesium fluoride - UNII:5N014C7IWU) Magnesium fluoride 12 [hp_X] in 35 g Magnesium sulfate heptahydrate (UNII: SK47B8698T) (Magnesium Cation - UNII:T6V3LHY838) Magnesium sulfate heptahydrate 12 [hp_X] in 35 g Ruta graveolens Flowering Top (UNII: N94C2U587S) (Ruta graveolens Flowering Top - UNII:N94C2U587S) Ruta graveolens Flowering Top 12 [hp_X] in 35 g Inactive Ingredients Ingredient Name Strength Medium-Chain Triglycerides (UNII: C9H2L21V7U) Cetostearyl Alcohol (UNII: 2DMT128M1S) Cetyl Alcohol (UNII: 936JST6JCN) Spermaceti (UNII: P86KHA8V3K) Water (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59469-066-35 1 in 1 BOX 04/12/2008 1 35 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:59469-066-30 1 in 1 BOX 04/12/2008 2 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 04/12/2008 Labeler - PEKANA Naturheilmittel GmbH (320344542) Establishment Name Address ID/FEI Business Operations PEKANA Naturheilmittel GmbH 320344542 MANUFACTURE(59469-066)