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NDC 11993-0001-01 ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED 70 mg/1 Details
ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED 70 mg/1
ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED is a TOPICAL PLASTER in the HUMAN OTC DRUG category. It is labeled and distributed by DERSAN PHARMACEUTICAL CO LTD. The primary component is CAPSAICIN.
Product Information
| NDC | 11993-0001 |
|---|---|
| Product ID | 11993-001_dbc77d91-1795-45cb-95ee-f1dae0b20e9f |
| 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 | ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Capsaicin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PLASTER |
| Route | TOPICAL |
| Active Ingredient Strength | 70 |
| Active Ingredient Units | mg/1 |
| Substance Name | CAPSAICIN |
| Labeler Name | DERSAN PHARMACEUTICAL CO LTD |
| 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 11993-0001-01 (11993000101)
| NDC Package Code | 11993-001-01 |
|---|---|
| Billing NDC | 11993000101 |
| Package | 24 POUCH in 1 BOX (11993-001-01) / 1 PLASTER in 1 POUCH |
| Marketing Start Date | 2007-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5145f124-268f-40d9-8fe5-1bb1ff7869c3 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Stop use and ask a doctor if
- excessive irritation of the skin develops
- condition worsens
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- when using for pain of arthritis:
- if pain persists for more than 10 days
- if redness is present
- in conditions affecting children under 12 years of age
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
- Peel apart from paper backing and apply directly to the affected area. If needed, cut plaster into small pieces and apply to affected area. It will be more effective when used after a bath.
- Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily.
- Children under 2 years: Do not use, consult a doctor.
SPL UNCLASSIFIED SECTION
Other information
- Not recommended for people with sensitive skin. May cause rash or festering.
- Not recommended for use when in contact with hot water. Burning sensation may occur.
- Do not apply on extremely hairy surface of skin. Highly adhesive plaster may hurt skin upon removal of product.
- Preserve in tight container after opening.
- Store at 20-25°C (68-77°F)
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED
capsaicin plaster |
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| Labeler - DERSAN PHARMACEUTICAL CO LTD (657669362) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DERSAN PHARMACEUTICAL CO LTD | 657669362 | manufacture(11993-001) | |
Revised: 6/2017
Document Id: dbc77d91-1795-45cb-95ee-f1dae0b20e9f
Set id: 5145f124-268f-40d9-8fe5-1bb1ff7869c3
Version: 2
Effective Time: 20170601