Label: BACK, NECK AND SCIATIC RESCUE- phytolacca decandra, gnaphalium polycephalum, hypericum perforatum, colocynthis, gelsemium sempervirens, guaiacum, ledum palustre, conium maculatum gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 43846-0076-1 - 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 17, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- INDICATIONS:
-
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 worsens · Symptoms last more than 7 days.
Do not use if safety seal is broken or missing.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
-
INACTIVE INGREDIENTS:
Water, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Sodium Hydroxide, acrylates/C10-30 Alkyl Acrylate Crosspolymer, Peg-33, Peg-8 Dimethicone, Peg-14, Aloe Vera, Tocopherols, Edetate Disodium (EDTA), Natural Plant extract, Potassium Sorbate, Arnica (Flower) Arnica Montana, Comfrey (Leaf) Symphytum Officinale, Kava (Root) Piper Methysticum, Poke (Root) Phytolacca Americana, St. John’s Wort (Leaf, Flower, Stem) Hypericum Perforatum, White Willow (Bark) Salix Alba, Yarrow (Flower) Achillea Millefolium, Lavender (buds) Lavandula Angustifolia, Ascorbic Acid.
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
-
INGREDIENTS AND APPEARANCE
BACK, NECK AND SCIATIC RESCUE
phytolacca decandra, gnaphalium polycephalum, hypericum perforatum, colocynthis, gelsemium sempervirens, guaiacum, ledum palustre, conium maculatum gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0076 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 4 [hp_X] in 1 g PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE 3 [hp_X] in 1 g HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE 3 [hp_X] in 1 g CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 6 [hp_X] in 1 g GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [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 WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A) PEG-8 DIMETHICONE (UNII: GIA7T764OD) POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) EDETATE DISODIUM (UNII: 7FLD91C86K) OREGANO (UNII: 0E5AT8T16U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) COMFREY LEAF (UNII: DG4F8T839X) MACROPIPER METHYSTICUM ROOT (UNII: BOW48C81XP) HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV) SALIX ALBA BARK (UNII: 205MXS71H7) ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) ASCORBIC ACID (UNII: PQ6CK8PD0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0076-1 57 g in 1 TUBE; Type 0: Not a Combination Product 03/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/17/2021 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0076) , api manufacture(43846-0076) , label(43846-0076) , pack(43846-0076)
