Label: BACK AND NECK RESCUE- hypericum perforatum, phytolacca decandra, guaiacum, ledum palustre, conium maculatum gel
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Contains inactivated NDC Code(s)
NDC Code(s): 43846-0020-1 - Packager: Peaceful Mountain, 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 March 18, 2013
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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 Condition worsens Symptoms last more than 7 days.
- DIRECTIONS
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INACTIVE INGREDIENTS
Aloe Vera, Arnical Montana (flower), Carbomer (Ultrez 21), Comfrey (leaf), Edetate Disodium, Lavender (buds), Origanox WS, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Potassium Sorbate, Water, Sodium Hydroxide Solution, Hypericum Perforatum, Ascorbic Acid, Vitamin E Oil, Salix Alba (bark), Achillea Millefolium (flower)
- 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 gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 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 GUAIAC (UNII: 03C8A0DFJ8) (GUAIAC - UNII:03C8A0DFJ8) GUAIAC 6 [hp_X] in 1 g LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE 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) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) COMFREY LEAF (UNII: DG4F8T839X) EDETATE DISODIUM (UNII: 7FLD91C86K) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) OREGANO (UNII: 0E5AT8T16U) 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) HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) ASCORBIC ACID (UNII: PQ6CK8PD0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SALIX ALBA BARK (UNII: 205MXS71H7) ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0020-1 105 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/18/2013 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0020)