Label: FAMILY WELLNESS MEDICATED WIPES- witch hazel solution
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Contains inactivated NDC Code(s)
NDC Code(s): 55319-031-48 - Packager: FAMILY DOLLAR
- 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 December 3, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
- open the lid on 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
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMILY WELLNESS MEDICATED WIPES
witch hazel solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 5 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALCOHOL (UNII: 3K9958V90M) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-031-48 48 in 1 POUCH; Type 0: Not a Combination Product 09/30/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 09/30/2012 Labeler - FAMILY DOLLAR (024472631)