NeilMed Hemorrhoidal Pain Relief Ointment with Aloe and Vitamin E 51g

Hemorrhoidal Pain Relief by

Drug Labeling and Warnings

Hemorrhoidal Pain Relief by is a Otc medication manufactured, distributed, or labeled by NeilMed Pharmaceuticals Inc., NeilMed pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEMORRHOIDAL PAIN RELIEF- hemorrhoidal pain relief with aloe and vitamin e ointment 
NeilMed Pharmaceuticals Inc.

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NeilMed Hemorrhoidal Pain Relief Ointment with Aloe and Vitamin E 51g

Active Ingredients

Active Ingredients
Glycerin 14.4%
Phenylephrine Hydrochloride 0.25%
Pramoxine Hydrochloride 1%
White petrolatum 15%

Drug Facts

Active Ingredients Purpose
Glycerin 14.4% ..................................................................... Protectant
Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor
Pramoxine Hydrochloride 1% ...................................... Local Anesthetic
White petrolatum 15% .......................................................... Protectant

Drug Facts :
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.

Drug Facts

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 prostate gland.

Ask a doctor or pharmacist before use

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 in the rectum by using fingers or any mechanical device or applicator

Stop use and ask doctor if:

􀁑􀀃Bleeding occurs 􀁑􀀃Condition worsens or does not improve within 7 days 􀁑􀀃An allergic reaction occurs 􀁑􀀃The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If pregnant or breast-feeding,

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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.

Other information:

store at 15°C - 30°C (59°F - 86°F)

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

TAMPER EVIDENT:

DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Important:

Please do not discard this printed box and any enclosed printed material. The inside final
product may not have all the details you require for the ongoing use of the product.

Package label

Hemorrhoidal pain relief aloe and vit E

HEMORRHOIDAL PAIN RELIEF 
hemorrhoidal pain relief with aloe and vitamin e ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 13709-320
Route of AdministrationRECTAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ALOE (UNII: V5VD430YW9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 13709-320-011 in 1 CARTON08/24/2023
151 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01508/24/202310/13/2023
Labeler - NeilMed Pharmaceuticals Inc. (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed pharmaceuticals Inc.799295915manufacture(13709-320)

Revised: 10/2023