Label: HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE cream
- NDC Code(s): 13709-324-01
- Packager: NeilMed pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 11, 2023
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- Drug Facts - Active Ingredients
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Purpose
Glycerin 14.4% ..................................................................... Protectant
Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor
Pramoxine Hydrochloride 1% ...................................... Local Anesthetic
White petrolatum 15% .......................................................... Protectant -
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 a doctor before use if you have
- Ask a doctor or pharmacist before use
- When using this product:
- Stop use and ask doctor if:
- If pregnant or breast-feeding
- Keep out of reach of children
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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 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. -
Inactive ingredients:
aloe barbadensis leaf extract, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, tocopherol acetate
- Questions?
- TAMPER EVIDENT:
- Important
- Use
- Package label _Outer carton
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE
hemorrhoidal pain relief with aloe and vitamine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13709-324 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 25 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 150 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 144 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) CETYL PALMITATE (UNII: 5ZA2S6B08X) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALOE (UNII: V5VD430YW9) POLYSORBATE 60 (UNII: CAL22UVI4M) CETYL ESTERS WAX (UNII: D072FFP9GU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13709-324-01 1 in 1 CARTON 10/11/2023 1 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 M015 10/11/2023 Labeler - NeilMed pharmaceuticals Inc. (799295915) Establishment Name Address ID/FEI Business Operations NeilMed Pharmaceuticals Inc. 799295915 manufacture(13709-324)