Label: PREPARATION H MAXIMUM STRENGTH- glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream
- NDC Code(s): 0573-2868-10, 0573-2868-20, 0573-2868-93, 0573-2868-98
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 5, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
INDICATIONS & USAGE
Uses
- for temporary relief of pain, soreness and burning
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
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WARNINGS
Warnings
For external use only
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.
When using this product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put into the rectum by using fingers or any mechanical device or applicator
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DOSAGE & ADMINISTRATION
Directions
- 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 applying cream.
- when first opening the tube, puncture foil seal with top end of cap
- apply externally or in the lower portion of the anal canal only
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
- thoroughly cleanse dispensing cap after each use and replace cover
- children under 12 years of age: ask a doctor
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum
- QUESTIONS
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PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
PREPARATION H ®
HEMORRHOIDAL
CREAMMulti-Symptom
Pain ReliefWITH
ALOENew Look,
SAME SIZE!- Soothing Pain Relief from Burning,
Itching, & Discomfort - Shrinks Swollen Hemorrhoidal Tissue
- Protects Irritated Tissue
- Relieves External Discomfort
- Proprietary Blend with Vitamin E
and Aloe
1 TUBE | NET WT 0.9 OZ (26 g)
- Soothing Pain Relief from Burning,
- PRINCIPAL DISPLAY PANEL - 51 g Tube Carton
- PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - NDC 0573-2868-98
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INGREDIENTS AND APPEARANCE
PREPARATION H MAXIMUM STRENGTH
glycerin, petrolatum, phenylephrine hcl, pramoxine hcl creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2868 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 144 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 150 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DEXPANTHENOL (UNII: 1O6C93RI7Z) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LAURETH-23 (UNII: N72LMW566G) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-2868-10 1 in 1 CARTON 07/01/2004 1 26 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0573-2868-20 1 in 1 CARTON 07/01/2004 2 51 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0573-2868-93 1 in 1 CARTON 01/01/2019 3 26 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:0573-2868-98 1 in 1 CARTON 05/12/2020 4 51 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 07/01/2004 Labeler - Haleon US Holdings LLC (079944263)