Welly Itch Fix
FDA Label NDC 72663-155

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Welly Health Pbc for the product Welly Itch Fix (NDC 72663-155). 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 other, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

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

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • external feminine, genital and anal itching.

    • Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

For external use only

Do Not Use

  • for the treatment of diaper rash, consult a doctor.
  • for external genital itching if you have a vaginal discharge, consult a doctor.

When Using This Product

  • avoid contact with eyes
  • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop Use And Ask A Doctor If

  • If condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

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.

Adults And Children 2 Years And Older

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

Children Under 2 Years Of Age

  • do not use. Consult a doctor.

For External Anal Itching:

  • adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • children under 12 years of age with external anal itching: consult a doctor.

Other Information

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

Inactive Ingredients

Aloe barbadensis leaf extract, Benzyl alcohol, Ceteareth-20, Cetearyl alcohol, Cetyl palmitate, Glycerin, Isopropyl myristate, Isostearyl neopentanoate, Methylparaben, PEG-40 stearate, Propylene glycol, Purified water

Principal Display Panel – Can Label

Welly First Aid Itch Fix 

NDC 72663-155-50

Hydrocortisone 1% Anti-itch Cream

2 tubes -0.57 oz(16g)   Total Net Wt 1.14oz (32g)

Principal Display Panel – Can Label (We Halftin Bellyband Finalmech Itchfix)

Principal Display Panel – Can Label (We Halftin Bellyband Finalmech Itchfix)

Principal Display Panel – 0.57Oz Tube Label

NDC 72663-155-50    Welly First Aid Itch fix

Hydrocortisone 1% Anti-itch Cream  Net Wt. 0.57 oz (16g)

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