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NDC 57520-0309-01 Arnica Plus 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g Details
Arnica Plus 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g
Arnica Plus is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Apotheca Company. The primary component is ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF.
Product Information
| NDC | 57520-0309 |
|---|---|
| Product ID | 57520-0309_d6d6113b-7d4d-4c8c-aba4-4db0bd6feb15 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Arnica Plus |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Arnica montana, Hamamelis virginiana, Rhus toxicodendron, |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 12; 12; 12 |
| Active Ingredient Units | [hp_X]/g; [hp_X]/g; [hp_X]/g |
| Substance Name | ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF |
| Labeler Name | Apotheca Company |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED HOMEOPATHIC |
| Application Number | n/a |
| Listing Certified Through | n/a |
Package
Package Images
NDC 57520-0309-01 (57520030901)
| NDC Package Code | 57520-0309-1 |
|---|---|
| Billing NDC | 57520030901 |
| Package | 100 g in 1 TUBE (57520-0309-1) |
| Marketing Start Date | 2011-03-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 008072be-c9cf-45ba-a500-b169d1a9531f Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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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 - Conditions worsens - Symptoms last more than 7 days.
SPL UNCLASSIFIED SECTION
INACTIVE INGREDIENTS: Aloe vera concentrate, Arnica montana flower, Carbomer, Demineralized water, Devil's claw root, Edetate disodium, Oregano, Sage, PEG-33, PEG-8, Dimethicone, PEG-14, Peppermint leaf, Phenoxyethanol, Caprylyl glycol, Sorbid acid, Potassium sorbate, Sodium hydroxide, Vitamin C, Vitamin E oil, White willow bark, Witch hazel bark.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| ARNICA PLUS
arnica montana, hamamelis virginiana, rhus toxicodendron, gel |
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| Labeler - Apotheca Company (844330915) |
| Registrant - Apotheca Company (844330915) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Apotheca Company | 844330915 | manufacture(57520-0309) , api manufacture(57520-0309) , label(57520-0309) , pack(57520-0309) | |
Revised: 4/2022
Document Id: d6d6113b-7d4d-4c8c-aba4-4db0bd6feb15
Set id: 008072be-c9cf-45ba-a500-b169d1a9531f
Version: 2
Effective Time: 20220427