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NDC 15533-0396-01 QUALITY CHOICE Medicated Wipes 50 g/100mL Details
QUALITY CHOICE Medicated Wipes 50 g/100mL
QUALITY CHOICE Medicated Wipes 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 | 15533-0396 |
|---|---|
| Product ID | 15533-396_faa7c23b-0edf-4a1c-a374-708856a6cb08 |
| 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 Wipes |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Witch Hazel |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CLOTH |
| Route | TOPICAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | g/100mL |
| 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 15533-0396-01 (15533039601)
| NDC Package Code | 15533-396-01 |
|---|---|
| Billing NDC | 15533039601 |
| Package | 48 PACKAGE in 1 POUCH (15533-396-01) / 4.68 mL in 1 PACKAGE |
| Marketing Start Date | 2021-07-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bde399cf-fd37-43e1-9692-b512e14f97b9 Details
Uses
Warnings
For external use only
When using this product
• do not use more than directed unless told to do so by a doctor
• do not put directly in the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
• rectal bleeding occurs
• condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
Directions
• open the lid on the top of the wipes pouch • peel back wipes seal, remove completely and discard
• grab the top wipe at the edge of the center fold and pull out of pouch
• close lid after each use to retain moisture
• 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. Do Not Flush.
• children under 12 years of age: consult a doctor
Inactive ingredients
SPL UNCLASSIFIED SECTION
Compare to the Active Ingredient in PREPARATION H®
Hemorrhoidal/Vaginal Wipes with Witch Hazel
Soothes & Comforts Irritated Areas
Pre-moistened Cooling Wipes
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
Other Uses:
• For external vaginal care – cleanse the area by gently wiping, patting or blotting. Repeat as needed.
• For use as a moist compress – if necessary, first cleanse the area. Fold new wipe to desired size and place in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.
TAMPER EVIDENT: DO NOT USE IF POUCH IS OPEN OR DAMAGED.
*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Preparation H® Medicated Wipes.
**Decolorized. Prop 65.
Made in China
INGREDIENTS AND APPEARANCE
| QUALITY CHOICE MEDICATED WIPES
witch hazel cloth |
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| Labeler - American Hygienics Corporation (545198454) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| American Hygienics Corporation | 545198454 | manufacture(15533-396) | |