![PREPARATION H RAPID RELIEF (GLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE) CLOTH [WYETH CONSUMER HEALTHCARE LLC]](https://medic.hrt.org//dailymed/images/49a93cfc-4ccd-4ef3-928f-901b9926f794/prep-h-02.jpg)
| NDC | 0573-0554-10, 0573-0554-20, 0573-0554-30 |
| Set ID | 49a93cfc-4ccd-4ef3-928f-901b9926f794 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist, Amide Local Anesthetic, Antiarrhythmic |
| Product Number | |
| Application Number | PART346 |
- 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
-
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 are presently 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
-
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
-
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)
-
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 FINAL part346 03/01/2019 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
