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NDC 69440-0008-15 Thritex 5 g/100g Details
Thritex 5 g/100g
Thritex is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Binger Consulting Corporation. The primary component is MENTHOL, UNSPECIFIED FORM.
Product Information
| NDC | 69440-0008 |
|---|---|
| Product ID | 69440-008_ff4b111d-47cb-490d-8122-af553944dc5d |
| Associated GPIs | 90070060005930 |
| GCN Sequence Number | 052742 |
| GCN Sequence Number Description | menthol ADH. PATCH 5 % TOPICAL |
| HIC3 | L6A |
| HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
| GCN | 19945 |
| HICL Sequence Number | 002608 |
| HICL Sequence Number Description | MENTHOL |
| Brand/Generic | Generic |
| Proprietary Name | Thritex |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Menthol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PATCH |
| Route | TOPICAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | g/100g |
| Substance Name | MENTHOL, UNSPECIFIED FORM |
| Labeler Name | Binger Consulting Corporation |
| 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 69440-0008-15 (69440000815)
| NDC Package Code | 69440-008-15 |
|---|---|
| Billing NDC | 69440000815 |
| Package | 15 PATCH in 1 BOX (69440-008-15) / 100 g in 1 PATCH |
| Marketing Start Date | 2015-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 32aca040-37f7-4195-8a5f-332d589a64d8 Details
Uses
Warnings
For external use only
Do not use
• on wounds or damaged skin
• if you are allergic to Menthol
When using this product
• do not cover with bandage
• use only as directed
• avoid contact with eyes and mucous membranes
Stop use and ask a doctor if
• conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days
• rash, itching or excessive skin irritation occurs
SPL UNCLASSIFIED SECTION
Directions adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
How to apply
• clean and dry affected area
• cut open pouch and remove patch
• remove protective film and apply directly to area of pain
• apply to affected area not more than 3 times daily
• wash hands with soap after applying patch
• reseal pouch containing unused patches.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| THRITEX
menthol patch |
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| Labeler - Binger Consulting Corporation (079635976) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Active Intelligence, LLC | 080416593 | manufacture(69440-008) | |