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NDC 00573-0558-07 PREPARATION H TOTABLES IRRITATION RELIEF WIPES 5 g/1 Details
PREPARATION H TOTABLES IRRITATION RELIEF WIPES 5 g/1
PREPARATION H TOTABLES IRRITATION RELIEF WIPES is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is WITCH HAZEL.
Product Information
| NDC | 00573-0558 |
|---|---|
| Product ID | 0573-0558_1ca0200f-0bf5-43ce-b230-9c142dd174e3 |
| Associated GPIs | 90970035004300 |
| GCN Sequence Number | 066102 |
| GCN Sequence Number Description | witch hazel MED. PAD 50 % TOPICAL |
| HIC3 | Q3D |
| HIC3 Description | HEMORRHOIDAL PREPARATIONS |
| GCN | 28286 |
| HICL Sequence Number | 021836 |
| HICL Sequence Number Description | WITCH HAZEL |
| Brand/Generic | Generic |
| Proprietary Name | PREPARATION H TOTABLES IRRITATION RELIEF WIPES |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | witch hazel |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CLOTH |
| Route | TOPICAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | g/1 |
| Substance Name | WITCH HAZEL |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00573-0558-07 (00573055807)
| NDC Package Code | 0573-0558-07 |
|---|---|
| Billing NDC | 00573055807 |
| Package | 10 PACKET in 1 CARTON (0573-0558-07) / 1 CLOTH in 1 PACKET |
| Marketing Start Date | 2010-11-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1953ec64-20ce-488b-8f14-44e15cc9e720 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
For external use only
When using this product
- •
- do not exceed the recommended daily dosage unless directed by a doctor
- •
- do not put this product into the rectum by using fingers or any mechanical device or applicator
SPL UNCLASSIFIED SECTION
Directions
- •
- adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
- •
- use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard
- •
- children under 12 years of age: consult a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| PREPARATION H TOTABLES IRRITATION RELIEF WIPES
witch hazel cloth |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |
Revised: 1/2022
Document Id: 1ca0200f-0bf5-43ce-b230-9c142dd174e3
Set id: 1953ec64-20ce-488b-8f14-44e15cc9e720
Version: 4
Effective Time: 20220106