Label: PREPARATION H RAPID RELIEF- glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride cream
- NDC Code(s): 0573-2843-01, 0573-2843-10
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 29, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purposes
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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 this cream.
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- 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
PREPARATION H ®
New Benefit
Now Reduces Swelling
See new labelRAPID RELIEF
WITH
LIDOCAINEHEMORRHOIDAL
CREAMLIDOCAINE
PHENYLEPHRINE HCl
GLYCERIN
WHITE PETROLATUM5%
HIGHEST STRENGTH
LIDOCAINE
AVAILABLE- Rapid numbing relief of pain,
itching & burning - Reduces swelling & provides
a soothing protective layer
1 TUBE | NET WT 0.75 OZ (23 g)
- Rapid numbing relief of pain,
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INGREDIENTS AND APPEARANCE
PREPARATION H RAPID RELIEF
glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2843 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 150 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 144 mg in 1 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength 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) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) LAURETH-23 (UNII: N72LMW566G) STEARETH-2 (UNII: V56DFE46J5) STEARETH-20 (UNII: L0Q8IK9E08) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) ALOE VERA LEAF (UNII: ZY81Z83H0X) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-2843-01 1 in 1 CARTON 11/01/2018 1 23 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0573-2843-10 1 in 1 CARTON 11/01/2018 2 28 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 11/01/2018 Labeler - Haleon US Holdings LLC (079944263) Establishment Name Address ID/FEI Business Operations Pf Soins De Sant? Sri 203812479 analysis(0573-2843) , label(0573-2843) , manufacture(0573-2843) , pack(0573-2843)
