Welly Superhero Supplies Kit
FDA Label NDC 72663-140

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 Superhero Supplies Kit (NDC 72663-140). 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 instant hand sanitizer gel, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Instant Hand Sanitizer Gel

Drug Facts

Active Ingredient

Ethyl Alcohol 66.5%

Lidocaine HCl 2.0%

Hydrocortisone 1.0%

Purpose

Antiseptic

First Aid Antibiotics

Topical pain relief

Anti-itch

Use

For handwashing to decrease bacteria on skin without soap and water.

Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use in eyes, if this happens, rinse thoroughly with water.

Stop use, ask a doctor if, irritation develops and persists for 72 hours.

For external use only

Do not use:

  • internally
  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients

    • Stop use and ask a doctor if

    • a rash or allergic reactions develops
    • condition worsens or persists

      • External use only

      Do not use

      • near eyes, if this happens, rinse thoroughly with water
      • in large quantities, particularly over raw or blistered areas

        • Stop use, ask doctor

        • if conditions worsen or last more than 7 days or clears up and returns.

          • For external use only

          Do not use

          • in eyes
          • for treatment of diaper rash
          • for feminine itching

            • Stop use, ask a doctor

            • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
            • with use of other hydrocortisone products

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If ingested, contact a Poison Control Center right away.

Keep out of reach of children. If ingested contact a Poison Control Center directly

Keep out of reach of children. If ingested, contact a Poison Control Center right away

Directions

  • Wet hands & wrists thoroughly with product and allow to dry without wiping
    • clean affected area
    • apply a small amount 1 to 3 times daily
    • may cover with a sterile bandage
      • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
      • children under 2: do not use, ask a doctor
        • apply to affected area not more than 3 to 4 times daily
        • children under 2: ask a doctor

Inactive Ingredients

aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

petrolatum

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Triple Antibiotic Ointment

Drug Facts

Active Ingredient (In Each Gram)

Bacitracin zinc 400 units

Neomycin sulfate (3.5mg Neomycin)

Polymyxin B sulfate 5000 units

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Temporary pain relief for minor burns

  • For temporary relief of itching associated with minor skin irritations, inflammation, or rashes.
  • Other uses of product should be only under the advice and supervision of a doctor.

Burn Gel

Drug Facts

1% Hydrocortisone Cream

Drug Facts

Packaging

Supercmp (Suprhcmp)

Supercmp (Suprhcmp)

Superkt (Suprklbl)

Superkt (Suprklbl)

* Please review the disclaimer below.