Family Wellness Maximum Strength Hydrocortisone
FDA Label NDC 55319-074

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 for the product Family Wellness Maximum Strength Hydrocortisone (NDC 55319-074). 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, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient                                                  Purpose

Hydrocortisone, USP 1%.......................................Anti-Itch

Otc - Purpose

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • jewelry
  • detergents
  • cosmetics
  • psoriasis
  • seborrhea dermatitis
  • temporarily relieves external anal and genital itching
  • other uses for this product should be only under the advice and supervision of a doctor

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

Otc - When Using

When using this product

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put this product into the rectum by using finger or any mechanical device or applicator

Otc - Stop Use

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.

Indications & Usage

Directions

  • for itching of 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

Storage And Handling

Other information

  • Store at room temperature 20°-25°C (68°-77°F)
  • lot no. & exp. date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

aloe vera leaf, butylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

Dosage & Administration

Distributed By:

Family Dollar Services, Inc.

10401 Monroe Rd.

Matthews, NC 28105 USA

Made in Korea

Package Label.Principal Display Panel

Image Description (7410)

Image Description (7410)

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