Label: PREMIER VALUE MEDICATED WIPES- witch hazel cloth
- NDC Code(s): 70108-028-01
- Packager: Ashtel Studios, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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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
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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 hemorroidal treatments, and then discard. Do Not Flush.
• children under 12 years of age: consult a doctor
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
COMPARABLE TO PREPARATION H ACTIVE INGREDIENT
Hemorrhoidal/Vaginal Wipes with Witch Hazel
• Pre-moistened Cooling Wipes
• Soothes & Comforts Irritated Areas
• 6 IN x 5 IN (15.2 cm x 12.7 cm)
If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
Distributed By: Pharmacy Value Alliance, LLC • 407 East Lancaster Avenue, Wayne, Pa 19087
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
- Packaging
-
INGREDIENTS AND APPEARANCE
PREMIER VALUE MEDICATED WIPES
witch hazel clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70108-028 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 0.02 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70108-028-01 48 in 1 BAG; Type 0: Not a Combination Product 12/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/10/2019 Labeler - Ashtel Studios, Inc. (148689180)
