NDC | 0363-1760-26 |
Set ID | 9191522e-f1d3-4922-8710-9827f78a823d |
Category | HUMAN OTC DRUG LABEL |
Packager | Walgreen Company |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART346 |
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ACTIVE INGREDIENT
Active ingredients Purpose
Glycerin 14.4%.................................................................................. Protectant
Phenylephrine HCL 0.25%................................................................... Vasoconstrictor
Pramoxine HCL 1%............................................................................. Local anaesthetic
White petrolatum 15%......................................................................... Protectant
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PURPOSE
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
- WARNINGS
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
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, puncture foil seal with top end of cap
- apply externally or in the lower portion of the anal canal only
- apply 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
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
aloe barbadensis leaf extract, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, distilled water, glycerol monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate hydrate, stearic acid, tocopherol acetate
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WALGREENS MAXIMUM STRENGTH HEMORRHOIDAL
glycerin, phenylephrine hcl, pramoxine hcl, and white petrolatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1760 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.144 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.0025 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 0.01 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 0.15 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ESTERS WAX (UNII: D072FFP9GU) CETYL PALMITATE (UNII: 5ZA2S6B08X) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1760-26 1 in 1 BOX 11/08/2016 1 26 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 final part346 02/25/2015 Labeler - Walgreen Company (008965063)