NDC | 43846-0003-1 |
Set ID | c0ee44ce-16b9-4ce5-8a98-e83f69c58776 |
Category | HUMAN OTC DRUG LABEL |
Packager | Peaceful Mountain, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- 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 Condition worsens Symptoms last more than 7 days.
- DIRECTIONS
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INACTIVE INGREDIENTS
Aloe Vera, Arnica Montana (flower), Carbomer (Ultrez 21), Comfrey (leaf), Edetate Disodium, Lavender (buds), Origanox WS, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Capryly 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:43846-0003 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 GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6) GUAIACUM OFFICINALE RESIN 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:43846-0003-1 105 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/20/2013 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0003)