Label: MUSCLE/TENDON PAIN AND STRESS RELIEF (calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla- smilax regelii spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 44911-0303-1 - Packager: Energique, 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 June 26, 2020
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.
Do not get into eyes.
If symptoms persist, consult a doctor.
Do not use if tamper evident seal is broken or missing.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
-
INACTIVE INGREDIENTS:
Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Arnica Montana (Flower)*, Larrea Tridentata (Leaf)*, Symphytum Officinale (Leaf)*, Croton Lechleri (Sap), Lavandula Angustifolia (Buds)*, Ionic Colloidal Silver Base, Melissa Officinalis (Leaf)*, [Peg-33, Peg-8 Dimethicone, Peg-14 (Silsense Copolyol-1 Silicone)], [Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, (Optiphen-Plus)], Phytolacca Americana (Berries)*, Phytolacca Americana (Root)*, Potassium Sorbate, Purified Water, Sodium Bicarbonate, Hypericum Perforatum (Aerial Parts)*, Tocopherol [Vitamin E Oil] (Derived From Soy Bean), Vitamin C Powder (Ascorbic Acid), Whey Protein Concentrate, Salix Alba (Bark)*, Achillea Millefolium (Flower)*
*Extract - QUESTIONS:
- PACKAGE LABEL DISPLAY:
-
INGREDIENTS AND APPEARANCE
MUSCLE/TENDON PAIN AND STRESS RELIEF
calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii) sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0303 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_X] in 1 mL CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED 30 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_X] in 1 mL PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 30 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 30 [hp_X] in 1 mL SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT 30 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) LARREA TRIDENTATA TOP (UNII: PK0TXD049P) COMFREY LEAF (UNII: DG4F8T839X) CROTON LECHLERI RESIN (UNII: GGG6W25C63) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) SILVER (UNII: 3M4G523W1G) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) 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) PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499) PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM BICARBONATE (UNII: 8MDF5V39QO) HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ASCORBIC ACID (UNII: PQ6CK8PD0R) WHEY (UNII: 8617Z5FMF6) SALIX ALBA BARK (UNII: 205MXS71H7) ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0303-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/18/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/18/2015 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0303) , api manufacture(44911-0303) , label(44911-0303) , pack(44911-0303)
