Label: F08 FRGV- allegheny monkeyflower, arnica montana, arnica montana flower, ceanothus integerrimus, ehrendorferia chrysantha, fagus sylvatica flower, ignatia amara, ilex aquifolium flower, malus sylvestris flower, mullein flower, nettleleaf giant hyssop, pinus sylvestris flower, salix alba flower solution/ drops
- NDC Code(s): 63479-0608-1
- Packager: Apex Energetics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 8, 2024
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ACTIVE INGREDIENT
Active Ingredients
Allegheny Monkeyflower Whole
6C 9C 12C
Arnica Montana
9C 12C 15C
Arnica Montana Flower
6C 9C 12C
Crab Apple Flower
6C 9C 12C
Deerbrush Whole
6C 9C 12C
English Holly Flowering Top
6C 9C 12C
European Beech Flowering Top
6C 9C 12C
Golden Eardrops Whole
6C 9C 12C
Ignatia Amara
9C 12C 15C
Mullein Flower
6C 9C 12C
Nettleleaf Giant Hyssop Whole
6C 9C 12C
Pinus Sylvestris Flowering Top
6C 9C 12C
White Willow Flowering Top
6C 9C 12C
- INDICATIONS & USAGE
- Warnings:
- Directions:
- Inactive Ingredients
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
F08 FRGV
allegheny monkeyflower, arnica montana, arnica montana flower, ceanothus integerrimus, ehrendorferia chrysantha, fagus sylvatica flower, ignatia amara, ilex aquifolium flower, malus sylvestris flower, mullein flower, nettleleaf giant hyssop, pinus sylvestris flower, salix alba flower solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63479-0608 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS SYLVESTRIS FLOWERING TOP (UNII: 2HEM73YI9I) (PINUS SYLVESTRIS FLOWERING TOP - UNII:2HEM73YI9I) PINUS SYLVESTRIS FLOWERING TOP 12 [hp_C] in 1 mL SALIX ALBA FLOWERING TOP (UNII: XBP5X7E70R) (SALIX ALBA FLOWERING TOP - UNII:XBP5X7E70R) SALIX ALBA FLOWERING TOP 12 [hp_C] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 15 [hp_C] in 1 mL VERBASCUM DENSIFLORUM FLOWER (UNII: N7FC535Q3R) (VERBASCUM DENSIFLORUM FLOWER - UNII:N7FC535Q3R) VERBASCUM DENSIFLORUM FLOWER 12 [hp_C] in 1 mL AGASTACHE URTICIFOLIA WHOLE (UNII: 8A94843BM7) (AGASTACHE URTICIFOLIA WHOLE - UNII:8A94843BM7) AGASTACHE URTICIFOLIA WHOLE 12 [hp_C] in 1 mL MIMULUS RINGENS WHOLE (UNII: W4KH5N2DCK) (MIMULUS RINGENS WHOLE - UNII:W4KH5N2DCK) MIMULUS RINGENS WHOLE 12 [hp_C] in 1 mL MALUS SYLVESTRIS FLOWER (UNII: 6ZJ8N1924Z) (MALUS SYLVESTRIS FLOWER - UNII:6ZJ8N1924Z) MALUS SYLVESTRIS FLOWER 12 [hp_C] in 1 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 15 [hp_C] in 1 mL ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER 12 [hp_C] in 1 mL CEANOTHUS INTEGERRIMUS WHOLE (UNII: N76K76PTFU) (CEANOTHUS INTEGERRIMUS WHOLE - UNII:N76K76PTFU) CEANOTHUS INTEGERRIMUS WHOLE 12 [hp_C] in 1 mL ILEX AQUIFOLIUM FLOWERING TOP (UNII: 5ENR9SAN1W) (ILEX AQUIFOLIUM FLOWERING TOP - UNII:5ENR9SAN1W) ILEX AQUIFOLIUM FLOWERING TOP 12 [hp_C] in 1 mL FAGUS SYLVATICA FLOWERING TOP (UNII: 21AF0IHY5U) (FAGUS SYLVATICA FLOWERING TOP - UNII:21AF0IHY5U) FAGUS SYLVATICA FLOWERING TOP 12 [hp_C] in 1 mL EHRENDORFERIA CHRYSANTHA WHOLE (UNII: 68HKD4QMJR) (EHRENDORFERIA CHRYSANTHA WHOLE - UNII:68HKD4QMJR) EHRENDORFERIA CHRYSANTHA WHOLE 12 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63479-0608-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 03/12/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/12/1996 Labeler - Apex Energetics Inc. (195816384)