Family Wellness Hemorrhoid Cream
FDA Label NDC 55319-981

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Family Wellness Hemorrhoid (NDC 55319-981). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, pupose, uses, warnings, directions, other information, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Glycerin 14.4%

Phenylephrine HCl 0.25%         

Pramoxine HCl 1%                   

White petrolatum 15%             

Pupose

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 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

Warnings

For external use only

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

    • Ask a doctor or pharmacist before useif 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

      • Stop use and ask a doctor if

      • 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.

Directions

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
  • when first opening the 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
  • 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.
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age: ask a doctor

Other Information

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

Inactive Ingredients:

Aloe Vera Leaf, Cellulose Gum, Cetyl Alcohol, Citric Acid, Disodium EDTA, Glyceryl Stearate SE, Laureth-23, Methylparaben, Mineral Oil, Panthenol, Propyl Gallate, Propylene Glycol, Sodium Benzoate, Steareth-2, Steareth-21, Stearyl Alcohol, Tocopherol, Tocopheryl Acetate, Water (purified), Xanthan Gum

Principal Display Panel

FamilyWellness       NDC 55319-981-25Maxium Strength Hemmorodial Cream NET WT 0.9oz (26g)

250540_fw_hemcream_0.9oz-tube (250540 Fw Hemcream 0.9oz Tube)

250540_fw_hemcream_0.9oz-tube (250540 Fw Hemcream 0.9oz Tube)

50540_fw_hemcream_0.9oz-carton (550540 Fw Hemcream 0.9oz Carton)

50540_fw_hemcream_0.9oz-carton (550540 Fw Hemcream 0.9oz Carton)

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