Label: PREPARATION H RAPID RELIEF- lidocaine, phenylephrine hydrochloride spray
- NDC Code(s): 0573-2890-01, 0573-2890-02
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 29, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
- INDICATIONS & USAGE
-
WARNINGS
Warnings
For external use only
Flammable:Do not use while smoking or near heat or flame
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 this product into the rectum by using fingers or any mechanical device or applicator
- Warning -avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.
- Warning -use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
-
DOSAGE & ADMINISTRATION
Directions
- Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad
- Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- Shake well before using
- Hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired
- Apply externally to the affected area up to 4 times daily
- Children under 12 years of age: consult a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- Additional Information
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PREPARATION H RAPID RELIEF
lidocaine, phenylephrine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2890 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) ISOBUTANE (UNII: BXR49TP611) MALIC ACID (UNII: 817L1N4CKP) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-2890-01 107.7 g in 1 CANISTER; Type 0: Not a Combination Product 02/01/2022 2 NDC:0573-2890-02 127.6 g in 1 CANISTER; Type 0: Not a Combination Product 02/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 02/01/2022 Labeler - Haleon US Holdings LLC (079944263)