Label: HEMORRHOIDAL PAIN RELIEF CREAM- glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream
- NDC Code(s): 0363-9127-01, 0363-9127-03
- Packager: WALGREENS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 4, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
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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
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
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put into 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, peel off the foil seal
- 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
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients aloe barbadensis leaf extract, butylated hydroxy anisole, cetostearyl alcohol, cetyl ester wax, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, vitamin E acetate
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL PAIN RELIEF CREAM
glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9127 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 GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LANOLIN (UNII: 7EV65EAW6H) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) CETYL ESTERS WAX (UNII: D072FFP9GU) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYL PALMITATE (UNII: 5ZA2S6B08X) POLYSORBATE 60 (UNII: CAL22UVI4M) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color white (White to off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9127-01 1 in 1 CARTON 01/15/2024 1 25.5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0363-9127-03 1 in 1 CARTON 01/15/2024 2 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 M017 01/15/2024 Labeler - WALGREENS (008965063) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 677604129 manufacture(0363-9127)
