NDC | 54973-3203-1, 54973-3203-2 |
Set ID | 74326a86-ff50-4597-e053-2991aa0ab959 |
Category | HUMAN OTC DRUG LABEL |
Packager | Hyland’s |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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Drug Facts
Active ingredients
Arnica Montana 1X HPUS
Bellis Perennis 2X HPUS
Hypericum Perforatum 2X HPUS
Ledum Palustre 2X HPUS
Ruta Graveolens 2X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Purpose
Arnica Montana 1X HPUS......................bruising, swelling,stiffness, muscle soreness and pain
Bellis Perennis 2X HPUS.................sprains, swelling and sore muscles
Hypericum Perforatum 2X HPUS.................shooting and radiating pains
Ledum Palustre 2X HPUS.......................................pain
Ruta Graveolens 2X HPUS..................sprains and twists
- Uses
- Warnings
- Directions
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Principal Display Panel - 70.9 Grams Gel Tube Carton
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INGREDIENTS AND APPEARANCE
MUSCLE THERAPY WITH ARNICA PAIN RELIEF GEL
arnica montana,bellis perennis,hypericum perforatum,ruta graveolensflowering top and rhododendron tomentosum leafy twig gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 1 [hp_X] in 1 g BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 2 [hp_X] in 1 g HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 2 [hp_X] in 1 g RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 2 [hp_X] in 1 g RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG 2 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color yellow (Light Yellow to Light Tan) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3203-1 1 in 1 CARTON 08/27/2018 1 70.9 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:54973-3203-2 10 g in 1 PACKET; Type 0: Not a Combination Product 08/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/27/2018 Labeler - Hyland’s (028570695) Establishment Name Address ID/FEI Business Operations Lifetech Resources, LLC 622559110 manufacture(54973-3203) , pack(54973-3203) , label(54973-3203)