Family Wellness Cream
FDA Label NDC 69571-009

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 69571-009). 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

Hydrocortisone 1%

Otc - Purpose

Purpose

Anti-itch

Indications & Usage

Uses

•temporarily relieves itching associated with minor skin

irritations, inflammation and rashes due to:

   •eczema  •psoriasis  •poison ivy, oak, sumac

   •insect bites  •detergents  •jewelry

   •cosmetics  •soaps  •saborrheiic dermatitis

•temproarily relieves external and genital itching

•other uses of this product should be under advice and

supervision of a doctor

Warnings

Warnings  For external use only.

Do not use:

•in the genital area if you have vaginal discharge. Consult a doctor.

•for the treatment of diaper rash. Consult a doctor.

When using this product:

•avoid contact with eyes.

•do not use more than directed unless told to do so by a doctor.

•do not put directly into rectum by using fingers or

any mechanical device or applicator.

Stop use and ask a doctor if

•condition worsens, symptoms persist for more than 7 days

or clear up and occur again within a few days, and do not

begin use of any other hydrocortisone product unless you

have asked a doctor  •rectal bleeding occurs

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

•for itching or skin irritation, inflammation and rashes:

   •adults and children 2 years of age and older: apply to

   affected area not more than 3 to 4 times daily

   •children under 2 years of age: ask a doctor

•for external and genital itching, adults:

   •when practical, clean the affected area with mild soap

   and warm waterand rinse thoroughly

   •gently dry by patting or blotting with toilet tissue or soft

   cloth before applying

   •apply to affected area not more than 3 to 4 times daily

   •children under 12 years of age: ask a doctor

Storage And Handling

Other information

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

Inactive Ingredient

Inactive ingredients aloe barbadensis leaf juice,

ceteastrearyl alcohol, edetate disodium, glyceryl

monostearate, methylparaben, mineral oil, polysorbate

60, propylene glycol, span 60, water, white petrolatum

Otc - Questions

Questions?  1-800-638-3800  Weekdays 0 AM to 4 PM EST

Package Label.Principal Display Panel

Image Description (Front Hydro)

Image Description (Front Hydro)

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