FDA Label for Welly Superhero Supplies Kit

View Indications, Usage & Precautions

Welly Superhero Supplies Kit Product Label

The following document was submitted to the FDA by the labeler of this product Welly Health Pbc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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