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NDC 15533-0395-01 Quality Choice Medicated Pads 0.0086 g/1 Details
Quality Choice Medicated Pads 0.0086 g/1
Quality Choice Medicated Pads is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by American Hygienics Corporation. The primary component is WITCH HAZEL.
Product Information
| NDC | 15533-0395 |
|---|---|
| Product ID | 15533-395_98440de9-4e56-4576-aa38-a4a2a3a59a45 |
| 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 | Quality Choice Medicated Pads |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Witch Hazel |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CLOTH |
| Route | TOPICAL |
| Active Ingredient Strength | 0.0086 |
| Active Ingredient Units | g/1 |
| Substance Name | WITCH HAZEL |
| Labeler Name | American Hygienics Corporation |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 15533-0395-01 (15533039501)
| NDC Package Code | 15533-395-01 |
|---|---|
| Billing NDC | 15533039501 |
| Package | 100 CLOTH in 1 JAR (15533-395-01) |
| Marketing Start Date | 2021-05-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e8422db7-5e7e-4c9c-9142-1f042a0f22de Details
Use
Warnings
For external use only. Avoid contact with eyes.
When using this product • do not exceed the recommended daily dosage unless directed by a doctor. • do not put directly into rectum by using fingers or any mechanical device.
Stop use and ask a doctor if • Rectal bleeding occurs • Condition worsens or does not improve within 7 days
Directions:
As hemorrhoidal treatment for adults:
• When practical, clean the affected area with mild soap and warm water and rinse thoroughly.
• Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
• Gently apply to the affected area by patting and then discard.
• Can be used up to six times daily or after each bowel movement.
Children under 12 years of age: ask a doctor
Inactive Ingredients
SPL UNCLASSIFIED SECTION
* Compare to the Active Ingredient in TUCKS® Medicated pads
Hemorrhoidal/Vaginal pads with Witch Hazel
Pre-moistened Pads Provide Temporary Relief of Burning, Itching and Local Discomfort Associated with Hemorrhoids
Other Uses For vaginal care - Cleanse the area by gently wiping, patting or blotting with pad and discard. Repeat as needed.
FOR YOUR PROTECTION, JAR IS SEALED. IF SEAL IS BROKEN OR MISSING, DO NOT USE.
• SATISFACTION • GUARANTEED 100% QC
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
Made in China
*This product is not manufactured or distributed by McNEIL-PPC, Inc., owner of the registered trademark TUCKS®.
INGREDIENTS AND APPEARANCE
| QUALITY CHOICE MEDICATED PADS
witch hazel cloth |
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| Labeler - American Hygienics Corporation (545198454) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| American Hygienics Corporation | 545198454 | manufacture(15533-395) | |