HEMORRHOIDAL CREAM WITH ALOE- glycerol, phenylephine, pramoxine, petrolatum cream 
Chain Drug Marketing Association

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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Hemorrhoidal Cream With Aloe

Drug Facts

Active Ingredient

Glycerol 14.4%

Purpose

Protectant

Active Ingredient

Phenylephrine HCI 0.25%

Purpose

Vasoconstrictor

Active Ingredient

Pramoxine HCI 1%

Purpose

Local Anesthetic

Active Ingredient

Petrolatum 15%

Purpose

Protectant

Uses

Helps relieve the local itching and discomfort associated with hemorrhoids

Temporarily shrinks hemorrhoidal tissue and relieves burning

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 tube, puncture foil seal with top end of cap

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

Warnings

For External Use Only

Ask doctor brfore use if you have

Heart Disease

Thyroid Disease

Diabetes

Difficulty urinating due to an enlarged prostate gland

Ask doctor before use if you are presently 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, cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum

Questions or Comments

Call 1-800-935-2362

Distributed By

C.D.M.A., Inc.®

43157 W 9 Mile Rd.

Novi, MI.48375, USA

1-00-935-2362

www.qualitychoice.com

Product of PRC

Packaging

QC Hemorrhoidal Max Cream .9oz.Hemorrhoidal Cream with Aloe

HEMORRHOIDAL CREAM WITH ALOE 
glycerol, phenylephine, pramoxine, petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-561
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN14.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) (UNII: 99H65D77XY)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-561-091 in 1 BOX07/08/2019
125.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/07/2019
Labeler - Chain Drug Marketing Association (011920774)
Registrant - Trifecta Pharmaceuticals USA (079424163)

Revised: 5/2023
Document Id: fc6152a2-7161-250f-e053-6394a90a951a
Set id: 8d1e7ebe-b702-2343-e053-2995a90ac66a
Version: 3
Effective Time: 20230523
 
Chain Drug Marketing Association