THERA PLUS HEMORRHOIDAL- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum cream

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredients

Glycerin 14.4%,
Phenylephrine HCl 0.25%
Pramoxine HCl 1%
White petrolatum 15%

Purpose

Protectant
Vasoconstrictor
Local anesthetic
Protectant

Uses

for temporary relief of pain, soreness and burning helps relieve the local itching and discomfort associated with hemorrhoids temporarily provides a coating for relief of anorectal discomforts temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful temporarily shrinks hemorrhoidal tissue

Warnings

For external use only.

Ask a doctor or pharmacist before use if you are

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 put this product into the rectum by using fingers or any mechanical device or applicator do not exceed recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

• bleeding occurs
• condition worsens or does not improve within 7 days
• the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. some people can develop allergic reactions to ingredients in this product.

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 with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. 
• apply externally to the affected area up to 4 times daily, especially at night or in the morning or after each bowel movement.
• apply externally or in the lower portion of the anal canal only.
• for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
• Children under 12 years of age: consult a doctor.

Other information

• store at room temperature 68 °- 77° F (20° - 25° C).

Inactive ingredients

aloe barbadensis leaf juice, carboxymethycellulose sodium, cetyl alcohol, methylparaben, mineral oil, mono-and di-glycerides, propylene glycol, propylparaben, purified water, stearic acid, tween 80, xanthan gum

Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Package Labeling:

INGREDIENTS AND APPEARANCE

THERA PLUS HEMORRHOIDAL 
glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	144 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	2.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (GLYCERIN - UNII:PDC6A3C0OX)	WHITE PETROLATUM	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-210-01	26 g in 1 TUBE; Type 0: Not a Combination Product	03/12/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	03/12/2026

Labeler - Fourstar Group USA, Inc. (140099503)

Registrant - Fourstar Group USA, Inc. (140099503)