Label: PREPARATION H RAPID RELIEF- glycerin, lidocaine, phenylephrine hydrochloride cloth
- NDC Code(s): 0573-0554-10, 0573-0554-20, 0573-0554-30
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 1, 2024
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- ACTIVE INGREDIENT
-
INDICATIONS & USAGE
Uses
- for temporary relief of pain, soreness and burning
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily reduces the swelling associated with irritated 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
- wash hands after use. Avoid contact with eyes
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put this product 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 with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with a tissue or soft cloth before applying wipe.
- apply externally to affected area up to 4 times daily.
- unfold wipe and gently apply to the affected area by patting and then discard.
- children under 12 years of age: ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
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PRINCIPAL DISPLAY PANEL - 10 Wipe Pouch Carton
PREPARATION H ®
New
RAPID RELIEF
WITH
LIDOCAINEHEMORRHOIDAL WIPES
Totables ®
LIDOCAINE
PHENYLEPHRINE HCl
GLYCERINHygienically-wrapped
for personal use- Quickly numbs away pain
- Soothes burning & itching
on contact - Reduces swelling of
inflamed tissue
10
Individually Wrapped
FLUSHABLE WIPES6 x 4 in. (15.2 x 10.2 cm)
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INGREDIENTS AND APPEARANCE
PREPARATION H RAPID RELIEF
glycerin, lidocaine, phenylephrine hydrochloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0554 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 200 mg LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0554-10 10 in 1 CARTON 03/01/2019 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0573-0554-20 20 in 1 CARTON 03/01/2019 2 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:0573-0554-30 30 in 1 CARTON 03/01/2019 3 1 in 1 POUCH; 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 03/01/2019 Labeler - Haleon US Holdings LLC (079944263)
