NDC | 52810-511-11 |
Set ID | 4beb936e-b0b6-4c7f-87ce-5adc480bc3d5 |
Category | HUMAN OTC DRUG LABEL |
Packager | PUREMEDY |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- QUESTIONS
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FUNGUS FREE
sambucus nigra flower, calendula officinalis flower, thuja occidentalis leafy twig, echinacea angustifolia salveProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52810-511 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER 1 [hp_X] in 100 mL CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER 1 [hp_X] in 100 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 1 [hp_X] in 100 mL ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 1 [hp_X] in 100 mL Inactive Ingredients Ingredient Name Strength OLIVE OIL (UNII: 6UYK2W1W1E) SAFFLOWER OIL (UNII: 65UEH262IS) YELLOW WAX (UNII: 2ZA36H0S2V) CANADA BALSAM (UNII: K304VI98I3) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) OREGANO LEAF OIL (UNII: 7D0CGR40U1) TEA TREE OIL (UNII: VIF565UC2G) AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52810-511-11 30 mL in 1 JAR; Type 0: Not a Combination Product 10/18/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/18/2012 Labeler - PUREMEDY (003552251) Establishment Name Address ID/FEI Business Operations PUREMEDY 003552251 manufacture(52810-511)