Label: FLEET- mineral oil and witch hazel kit
- NDC Code(s): 0132-0705-00
- Packager: C.B. Fleet Company, Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated June 29, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 118 mL delivered dose)
- Purpose
- Uses
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Warnings
For rectal use only
Ask a doctor before using this product if you
- have a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
- have a sudden change in bowel habits lasting more than 2 weeks
- Directions
- Other information
- Questions?
- Active ingredient
- Purpose
- Uses
- Warnings
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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
- adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. if necessary, repeat until all matter is removed from the area.
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLEET
mineral oil and witch hazel kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0705 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0705-00 1 in 1 CARTON; Type 0: Not a Combination Product 02/15/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, WITH APPLICATOR 133 mL Part 2 1 CARTON 2 Part 1 of 2 FLEET
mineral oil enemaProduct Information Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 100 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 CARTON 1 133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 05/01/2002 Part 2 of 2 FLEET
witch hazel clothProduct Information 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BRONOPOL (UNII: 6PU1E16C9W) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) GLYCERIN (UNII: PDC6A3C0OX) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) PEG-75 LANOLIN (UNII: 09179OX7TB) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part346 02/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/15/2019 Labeler - C.B. Fleet Company, Inc. (003119054)