Family Wellness Cream
FDA Label NDC 69571-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Front Pharmaceutical Plc for the product Family Wellness (NDC 69571-004). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients (in each gram)

Glycerin 14.4%

Phenylephrine HCL 0.25%

Pramoxine HCL 1%

White petrolatum 15%

Otc - Purpose

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Indications & Usage

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

Warnings

For external use only.

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

    • Ask a doctor before use if you have

    •heart disease  •high blood pressure  •thyroid disease  •diabetes

    •trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are presently taking a prescription

    drug for high blood pressure.

    Stop use and ask a doctor if

    •bleeding occurs  •condition worsens or does not improve within 7 days

    -if the symptoms being treated do not subside or ir 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.

Otc - 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.

Dosage & Administration

Directions Adults:

-when practical, cleanse the affected area with mild soap and warm water and

rinse thoroughly. Gentlydry 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 r

in the morningor after each bowel movement.

hildren under 12 years of age: consult a doctor.

Storage And Handling

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

Inactive Ingredient

Inactive ingredients aloe barbadensis leaf extract,

carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate,

methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80,

water, xanthan gum

Package Label.Principal Display Panel

Image Description (Hema Label)

Image Description (Hema Label)

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