Label: BACK AND NECK RESCUE- hypericum perforatum, phytolacca decandra, guaiacum, ledum palustre, conium maculatum lotion
- NDC Code(s): 43846-0015-1
- Packager: Peaceful Mountain, Inc.
- Category: HUMAN PRESCRIPTION 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 June 13, 2024
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- ACTIVE INGREDIENTS
- INDICATIONS
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WARNINGS
For external use only. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product Do not get into eyes. Stop use and ask a doctor if conditions worsen, symptoms last more than 7 days.
- DIRECTIONS
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INACTIVE INGREDIENTS
Aloe Vera 10X Concentrate, Arnica Montana, Carbomer, Comfrey (leaf), Edetate Disodium (EDTA), Lavandula Spp., Natural plant extract, PEG-33, PEG-8 Dimethicone and PEG-14. Phenoxyethanol, Caprylyl Glycol and Sorbic Acid, Potassium Sorbate, Purified Water, Sodium Hydroxide Solution, Hypericum Perforatum, Ascorbic Acid, Vitamin E Oil, Salix Alba, Achillea Millefolium.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BACK AND NECK RESCUE
hypericum perforatum, phytolacca decandra, guaiacum, ledum palustre, conium maculatum lotionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43846-0015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM WHOLE - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 3 [hp_X] in 1 g PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 3 [hp_X] in 1 g GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6) GUAIACUM OFFICINALE RESIN 6 [hp_X] in 1 g RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG 6 [hp_X] in 1 g CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP 30 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) COMFREY ROOT (UNII: M9VVZ08EKQ) EDETATE DISODIUM (UNII: 7FLD91C86K) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) OREGANO FLOWERING TOP (UNII: 7K91ZBK8GJ) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) PEG-8 DIMETHICONE (UNII: GIA7T764OD) POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) ASCORBIC ACID (UNII: PQ6CK8PD0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SALIX ALBA BARK (UNII: 205MXS71H7) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0015-1 7 g in 1 PACKET; Type 0: Not a Combination Product 09/19/2012 07/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/19/2012 07/31/2024 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0015) , api manufacture(43846-0015) , label(43846-0015) , pack(43846-0015)