Welly Human Repair Kit
FDA Label NDC 72663-130

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 Human Repair Kit (NDC 72663-130). 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 triple antibiotic ointment, active ingredient (in each gram), purpose, uses, 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

Triple Antibiotic Ointment

Drug Facts

Active Ingredient (In Each Gram)

Bacitracin zinc 400 units

Neomycin sulfate (3.5mg Neomycin)

Polymyxin B sulfate 5000 units

Purpose

First Aid Antibiotics

Anti-itch

Antiseptic

Uses

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

Warnings

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 other allergic reaction develops
    • condition worsens or persists

      • 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

          • 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.

Otc - Keep Out Of Reach Of Children

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 right away

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

Directions

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

Inactive Ingredients

petrolatum

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

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

1% Hydrocortisone Cream

Drug Facts

Active Ingredient

Hydrocortisone 1.0%

Ethyl Alcohol 66.5%

Instant Hand Sanitizer Gel

Drug Facts

Use

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

Packaging

Rprcomp (Humncmp)

Rprcomp (Humncmp)

Rprkit (Humnkt)

Rprkit (Humnkt)

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