Thera Plus Hemorrhoidal Cream

Thera Plus Hemorrhoidal Cream
SPL v2
SPL
SPL Set ID 87143a7a-7b2d-4b67-afda-2355697e7300
Route
TOPICAL
Published
Effective Date 2024-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (144 mg) Petrolatum (150 mg) Phenylephrine (2.5 mg) Pramoxine (10 mg)
Inactive Ingredients
Aloe Vera Leaf Carboxymethylcellulose Sodium, Unspecified Cetyl Alcohol Methylparaben Mineral Oil Propylene Glycol Propylparaben Water Stearic Acid Polysorbate 80 Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-03

Description

Glycerol 14.4% Petrolatum 15%  Phenylephrine hydrochloride 0.25% Pramoxine hydrochloride 1%

Purpose

Protectant Vasoconstrictor Local anesthetic


Medication Information

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Description

Glycerol 14.4% Petrolatum 15%  Phenylephrine hydrochloride 0.25% Pramoxine hydrochloride 1%

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 in amed irritated anorectal surface to help make bowel movements less painful
  • temporarily shrinks hemorrhoidal tissue
Warnings

For external use only.

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.
Drug Facts

Questions?

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

Other Information
  • store at room temperature 68 °- 77° F (20° - 25° C).
Package Labeling:

Active Ingredients

Glycerol 14.4%

Petrolatum 15% 

Phenylephrine hydrochloride 0.25%

Pramoxine hydrochloride 1%

Inactive Ingredients

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

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).

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • urinating due to an enlarged prostate gland

Structured Label Content

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 in amed irritated anorectal surface to help make bowel movements less painful
  • temporarily shrinks hemorrhoidal tissue
Purpose

Protectant

Vasoconstrictor

Local anesthetic

Warnings

For external use only.

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.
Drug Facts

Questions?

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

Other Information (Other information)
  • store at room temperature 68 °- 77° F (20° - 25° C).
Package Labeling:

Active Ingredients (Active ingredients)

Glycerol 14.4%

Petrolatum 15% 

Phenylephrine hydrochloride 0.25%

Pramoxine hydrochloride 1%

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • urinating due to an enlarged prostate gland

Advanced Ingredient Data


Raw Label Data

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