NDC | 54973-3085-1, 54973-3085-2 |
Set ID | 2da6e7c1-e747-4467-8f5b-1d38eeadac62 |
Category | HUMAN OTC DRUG LABEL |
Packager | Hyland's |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- PURPOSE
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SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients Purpose Arnica Montana 2X HPUS bruising; stiffness; pain; trauma Bellis Perennis 3X HPUS muscular soreness; fatigue; sprains Hypericum Perforatum 3X HPUS weakness in limbs; joint pain Ledum Palustre 3X HPUS swelling; aches & pains; inflammation Ruta Graveolens 3X HPUS pain in limbs, joints & bones “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
- Uses
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Warnings
For External Use Only. DO NOT USE ON OPEN WOUNDS.
As with any drug, ask a doctor before use if pregnant or nursing a baby. Consult a physician if symptoms persist for more than 7 days or worsen.
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 85g Tube Carton
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INGREDIENTS AND APPEARANCE
MUSCLE THERAPY WITH ARNICA
arnica montana, bellis perennis, hypericum perforatum, ledum palustre twig, and ruta graveolens flowering top gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3085 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 2 [hp_X] in 1 g BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 3 [hp_X] in 1 g HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 3 [hp_X] in 1 g LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 3 [hp_X] in 1 g RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength CHONDRUS CRISPUS (UNII: OQS23HUA1X) HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color brown (light brown) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3085-1 1 in 1 CARTON 01/15/2009 1 85 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:54973-3085-2 5 g in 1 PACKET; Type 0: Not a Combination Product 01/15/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/15/2009 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3085) Establishment Name Address ID/FEI Business Operations Diamond Wipe International, Inc. 161104729 manufacture(54973-3085) , pack(54973-3085) Establishment Name Address ID/FEI Business Operations Lifetech Resources 622559110 manufacture(54973-3085) , pack(54973-3085)