MAXIMUM STRENGTH HEMORRHOIDAL CREAM WITH ALOE- glycerin, phenylephine hci, pramoxine hci, petrolatum cream

Maximum Strength Hemorrhoidal Cream with Aloe by

Drug Labeling and Warnings

Maximum Strength Hemorrhoidal Cream with Aloe by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, Trifecta Pharmaceuticals USA, Zhejiang Jingwei Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Glycerin 14.4%

Purpose

Protectant

Active Ingredient

Phenylephrine HCI 0.25%

Purpose

Vasoconstrictor

Active Ingredient

Pramoxine HCI 1%

Purpose

Local Anesthetic

Active Ingredient

White Petrolatum 15%

Purpose

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

Stop use and ask a doctor

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 doctor 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, clean the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.

When first opening the tube, remove the foil seal.

Apply externally or in the lower portion of the anal canal only

Apply externally 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 applicator. Attach applicator to tube. Lubricate applicator well, then gently insert applicator pathway into anus.

Thoroughly cleanse applicator after each use and replace cover.

Children under 12 years of age: ask a doctor

Warnings

For External Use Only

Ask doctor brfore use if you have

Heart Disease

High blood pressure

Thyroid Disease

Diabetes

Difficulty urinating due to an enlarged prostate gland

Ask doctor before use if you arepresently taking a prescription 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

Other Information

Store at room temperature 20º-25ºC (68º-77ºF)

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H®

Inactive Ingredients

Aloe barbadensis leaf juice, carboxmethylcellulose sodium, cetearyl alcohol, mono and diglycerides, methylparaben, light mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum

Questions or Comments

Call 1-800-935-2362

Distributed By

CDMA Inc.®

Novi, MI.48375, USA

800-935-2362

www.qualitychoice.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH HEMORRHOIDAL CREAM WITH ALOE 
glycerin, phenylephine hci, pramoxine hci, petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	15 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	14.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONO- AND DICAPRYLATE (UNII: 34966F76M6)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) (UNII: 99H65D77XY)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-330-01	1 in 1 BOX	07/08/2025
1		25.5 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	07/08/2025

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Trifecta Pharmaceuticals USA (079424163)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Jingwei Pharmaceutical Co., Ltd.		530876549	manufacture(83324-330)