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NDC 28691-1004-02 Unnaplast 3 mg/cm2 Details
Unnaplast 3 mg/cm2
Unnaplast is a TOPICAL DRESSING in the HUMAN OTC DRUG category. It is labeled and distributed by Pharmaplast SAE. The primary component is ZINC OXIDE.
Product Information
| NDC | 28691-1004 |
|---|---|
| Product ID | 28691-1004_3d0f4e68-4c15-45bc-9fce-3cba2c88fe97 |
| 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 | Unnaplast |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zinc Oxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | DRESSING |
| Route | TOPICAL |
| Active Ingredient Strength | 3 |
| Active Ingredient Units | mg/cm2 |
| Substance Name | ZINC OXIDE |
| Labeler Name | Pharmaplast SAE |
| Pharmaceutical Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part347 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 28691-1004-02 (28691100402)
| NDC Package Code | 28691-1004-2 |
|---|---|
| Billing NDC | 28691100402 |
| Package | 1 POUCH in 1 BOX (28691-1004-2) / 9140 cm2 in 1 POUCH |
| Marketing Start Date | 2021-02-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e0ac4390-4fad-466f-9f96-c1a499d37cef Details
Uses:
Warnings:
• Reuse of the product increases risk of infection.
• Dispose carefully in a manner preventing cross-contamination.
• For external use only.
• Do not make reverse turns while wrapping Unnaplast® bandage.
• Do not use if you are hypersensitive to the product or any of its components.
• Do not use on grossly macerated skin.
• If condition worsens or does not improve within 7 days, consult a doctor.
• Avoid contact with eyes.
Directions:
1. Position the patient’s leg in a slightly flexed position.
2. Apply Unnaplast® in a circular motion from the foot to the knee. The wrap should be snug but not tight. To cover the area completely, be sure each turn overlaps the previous one by half the bandage’s width.
3. Continue wrapping the patient’s leg up to the knee, using firm even pressure. Mold the boot with your free hand as you apply the bandage to make it smooth.
4. Apply an elastic or cohesive bandage to secure dressing and maintain compression.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| UNNAPLAST
zinc oxide dressing |
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| Labeler - Pharmaplast SAE (644773319) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Pharmaplast SAE | 644773319 | manufacture(28691-1004) | |