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NDC 70000-0208-01 Leader Ultra Strength Muscle Rub 40; 100; 300 mg/g; mg/g; mg/g Details
Leader Ultra Strength Muscle Rub 40; 100; 300 mg/g; mg/g; mg/g
Leader Ultra Strength Muscle Rub is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba LEADER. The primary component is CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.
Product Information
| NDC | 70000-0208 |
|---|---|
| Product ID | 70000-0208_4dd04a0a-4683-4513-ac17-2d76095a575d |
| Associated GPIs | 90809903253740 |
| GCN Sequence Number | 059179 |
| GCN Sequence Number Description | methyl salicylate/menth/camph CREAM (G) 30%-10%-4% TOPICAL |
| HIC3 | L6A |
| HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
| GCN | 24719 |
| HICL Sequence Number | 002581 |
| HICL Sequence Number Description | METHYL SALICYLATE/MENTHOL/CAMPHOR |
| Brand/Generic | Generic |
| Proprietary Name | Leader Ultra Strength Muscle Rub |
| Proprietary Name Suffix | Topical Analgesic |
| Non-Proprietary Name | Camphor (Synthetic), Menthol, Unspecified Form, and Methyl Salicylate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 40; 100; 300 |
| Active Ingredient Units | mg/g; mg/g; mg/g |
| Substance Name | CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE |
| Labeler Name | Cardinal Health, 110 dba LEADER |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0208-01 (70000020801)
| NDC Package Code | 70000-0208-1 |
|---|---|
| Billing NDC | 70000020801 |
| Package | 1 TUBE in 1 CARTON (70000-0208-1) / 113 g in 1 TUBE |
| Marketing Start Date | 2017-05-24 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.03121 |
| Pricing Unit | GM |
| Effective Date | 2023-08-23 |
| NDC Description | MUSCLE RUB ULTRA STR CREAM |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 9d99a900-60e0-454c-98e0-2c63eb910cf1 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
For external use only
Do not use
- ♦
- with a heating pad
- ♦
- on wounds, damaged, broken or irritated skin
- ♦
- on a child under 12 years of age with arthritis-like conditions
When using this product
- ♦
- use only as directed
- ♦
- do not swallow
- ♦
- do not bandage tightly
- ♦
- avoid contact with the eyes and mucous membranes
Directions
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
INGREDIENTS AND APPEARANCE
| LEADER ULTRA STRENGTH MUSCLE RUB
TOPICAL ANALGESIC
camphor (synthetic), menthol, unspecified form, and methyl salicylate cream |
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| Labeler - Cardinal Health, 110 dba LEADER (063997360) |
| Registrant - Garcoa, Inc (036464697) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Garcoa, Inc | 036464697 | MANUFACTURE(70000-0208) | |
Revised: 6/2021
Document Id: 4dd04a0a-4683-4513-ac17-2d76095a575d
Set id: 9d99a900-60e0-454c-98e0-2c63eb910cf1
Version: 3
Effective Time: 20210625