HEMORRHOIDAL CREAM- hemorrhoidal cream cream 
Walgreens

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Glycerin 14.4%

Phenylephrine HCL  0.25%

Pramoxine HCl  1%

White petrolatum  15%

Purpose

Protectant

Vasoconstrictor

Local anasthetic

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 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 the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

-bleeding occurs

-condition worsens or does not improve within 7 days

-an allergic reaction develops

-the symptom being treated does not subside or if redness, irritation, swelling pain, or other symptoms develop or increase

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.

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.  Lubrcate 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.

Directions

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. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.

Other information

store at 20-25oC (68-77oF)

Inactive ingredients

Aloe barbadensis leaf extract, butylated hydroxytoluene, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate, stearic acid, stearyl alcohol, vitamin E, water

Carton label

carton label

Tube label

Tube label

HEMORRHOIDAL CREAM 
hemorrhoidal cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0641
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN14.4 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 37.45 g  in 100 g
POLYSORBATE 60 (UNII: CAL22UVI4M) 10 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 4 g  in 100 g
STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 3.3 g  in 100 g
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 3.2 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP) 2 g  in 100 g
CETYL PALMITATE (UNII: 5ZA2S6B08X) 1 g  in 100 g
ALOE (UNII: V5VD430YW9) 1 g  in 100 g
SODIUM CITRATE (UNII: 1Q73Q2JULR) 1 g  in 100 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.8 g  in 100 g
STEARIC ACID (UNII: 4ELV7Z65AP) 2 g  in 100 g
LANOLIN (UNII: 7EV65EAW6H) 0.5 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.20 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.10 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0641-091 in 1 PACKAGE03/25/2018
1NDC:0363-0641-1025.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/25/2018
Labeler - Walgreens (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Unipack009248480manufacture(0363-0641)

Revised: 12/2020
Document Id: 8f8cfc99-75e8-4681-bf2b-88e0981641a1
Set id: 1ac2b2ae-c090-483b-ad2c-1374552add4a
Version: 2
Effective Time: 20201222
 
Walgreens