HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE- hemorrhoidal pain relief with aloe and vitamine cream 
NeilMed pharmaceuticals Inc.

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Hemorrhoidal Pain Relief Cream with Aloe and Vitamin E

Drug Facts - Active Ingredients

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

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:

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

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.

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?

Questions? 1 (877) 477-8633

TAMPER EVIDENT:

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Important

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.

Use

swollen hemorrhoidal tissue, to get quick temporary relief from pain, burning, itching& irritation

Package label _Outer carton

Pain Relief Cream with Aloe

HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE 
hemorrhoidal pain relief with aloe and vitamine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-324
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE25 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-324-011 in 1 CARTON10/11/2023
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 DrugM01510/11/2023
Labeler - NeilMed pharmaceuticals Inc. (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed Pharmaceuticals Inc.799295915manufacture(13709-324)

Revised: 10/2023
Document Id: 076b5021-8ba1-0204-e063-6294a90a3337
Set id: 076b5021-8ba0-0204-e063-6294a90a3337
Version: 1
Effective Time: 20231011
 
NeilMed pharmaceuticals Inc.