Label: PREPARATION H- cocoa butter, phenylephrine hydrochloride, and witch hazel kit
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- NDC Code(s): 0573-2884-12
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- 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 February 8, 2023
If you are a consumer or patient please visit this version.
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- Active Ingredients
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Uses
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- helps relieve the local itching and discomfort associated with hemorrhoids
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- temporarily relieves burning and shrinks hemorrhoidal tissue
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- temporarily provides a coating for relief of anorectal discomforts
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- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
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Warnings
For rectal use only
Ask a doctor before use if you have
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
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Directions
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- adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product.
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- detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
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- children under 12 years of age: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
When using this product
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- do not exceed the recommended daily dosage unless directed by a doctor
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- do not put this product into the rectum by using fingers or any mechanical device or applicator
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Directions
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- adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
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- use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard
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- children under 12 years of age: consult a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
PREPARATION H
cocoa butter, phenylephrine hydrochloride, and witch hazel kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2884 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-2884-12 1 in 1 CARTON; Type 0: Not a Combination Product 07/01/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 12 Part 2 1 APPLICATOR 4 Part 1 of 2 PREPARATION H
cocoa butter and phenylephrine hydrochloride suppositoryProduct Information Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 2211 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 6.25 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color YELLOW (Light Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 12 in 1 BLISTER PACK; 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 07/01/2015 Part 2 of 2 PREPARATION H TOTABLES IRRITATION RELIEF WIPES
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) CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Product Characteristics Color WHITE (white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 in 1 APPLICATOR; 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 07/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/01/2015 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
