NDC | 54973-3210-1 |
Set ID | df3f0398-e8c0-4fc7-a551-032cfbab4d16 |
Category | HUMAN OTC DRUG LABEL |
Packager | Hyland's |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active ingredients Purpose "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Arnica Montana 2X HPUS pain, swelling, bruising, soreness, sensitivity to touch Bellis Perennis 6X HPUS soreness Hypericum Perforatum 3X HPUS pain, bruising, soreness Ruta Graveolens 6X HPUS aching pain, swelling, bruised sensation, soreness - Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 22.68 g Tube Blister Pack
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INGREDIENTS AND APPEARANCE
4KIDS BUMPS N BRUISES WITH ARNICA
arnica montana, bellis perennis, hypericum perforatum, and ruta graveolens flowering top ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3210 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 6 [hp_X] in 1 g HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 3 [hp_X] in 1 g RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) CANDELILLA WAX (UNII: WL0328HX19) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) JOJOBA OIL (UNII: 724GKU717M) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) OLIVE OIL (UNII: 6UYK2W1W1E) ROSEMARY OIL (UNII: 8LGU7VM393) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) SPANISH THYME OIL (UNII: U14667H96E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3210-1 1 in 1 BLISTER PACK 05/28/2015 1 22.68 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/28/2015 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3210) , pack(54973-3210) Establishment Name Address ID/FEI Business Operations Lifetech Resources 622559110 manufacture(54973-3210) , pack(54973-3210)