HEMORRHOIDAL CREAM WITH LIDOCAINE- glycerol, phenylephine, pramoxine, petrolatum cream

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredient

Glycerol 14.4%

Purpose

Protectant

Active Ingredient

Phenylephrine HCI 0.25%

Purpose

Vasoconstrictor

Active Ingredient

Lidocaine 5%

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 a health professional before use

Ask a Doctor 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.

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 cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.

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

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

Other Information

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

This product is not manufactured or distributed by Haleon US Holdings LLC, distributor of Preparation H® Rapid Relief Cream

Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Citric acid Monohydrate, Dexpanthenol, EDTA Disodium, Light mineral oil, Methylparaban,

Mono and di glycerides, Octadecyl alcohol, polysorbate 80,

Propyl 4-hydroxybenzoate,, propylene glycol, purified water, Vitamin E.

Questions or Comments

Call 1-888-296-9067

Distributed By

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301, USA

1-888-296-9067

www.trifecta-pharma.com

SKU: 4043-FBA

LABEL

LABEL

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL CREAM WITH LIDOCAINE 
glycerol, phenylephine, pramoxine, petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-181
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (PETROLATUM - UNII:4T6H12BN9U)	WHITE PETROLATUM	15 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	14.4 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL MONO- AND DICAPRYLATE (UNII: 34966F76M6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-181-01	1 in 1 BOX	04/10/2026
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69396-181-03	3 in 1 BOX	04/10/2026
2		28 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	04/10/2026

Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)