FDA Label for Welly Excursion First Aid Kit

View Indications, Usage & Precautions

Welly Excursion First Aid 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.

1% Hydrocortisone Cream



Drug Facts


Active Ingredient



Hydrocortisone 1.0%


Purpose



Anti-itch

First Aid Antibiotics

Pain reliever/fever reducer


Uses



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

    • temporarily relieves minor aches and pains due to:
    • muscular aches
    • backache
    • toothache
    • menstrual cramps
    • headache
    • the common cold
    • minor pain of arthritis
    • temporarily reduces fever

Warnings



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

      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
        • Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

          • shock
          • facial swelling
          • asthma (wheezing)
          • rash
          • skin reddening
          • blisters
          • hives
          • If an allergic reaction occurs, stop use and seek medical help right away.

            Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

            • take more or for a longer time than directed
            • take a blood thinning (anticoagulant) or steroid drug
            • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
            • have had stomach ulcers or bleeding problems
            • have 3 or more alcoholic drinks every day while using this product
            • Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

              Do not use

              • if you have ever had an allergic reaction to any other pain reliever/fever reducer
              • right before or after heart surgery
              • Ask a doctor before use if

                • stomach bleeding warning applies to you
                • you have a history of stomach problems, such as heartburn.
                • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
                • you are taking a diuretic
                • you have problems or serious side effects from taking pain relievers or fever reducers
                • Ask a doctor or pharmacist before use if you are

                  • under a doctor’s care for any serious condition
                  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
                  • taking any other drug
                  • When using this product

                    • take with food or milk if stomach upset occurs
                    • Stop use and ask a doctor if

                      • you experience any of the following signs of stomach bleeding.
                      • Feel faint
                      • have bloody or black stools
                      • vomit blood
                      • have stomach pain that does not get better
                      • you have symptoms of heart problems or stroke:
                      • chest pain
                      • slurred speech
                      • leg swelling
                      • trouble breathing
                      • weakness in one part or side of body
                      • pain gets worse or lasts more than 10 days
                      • fever gets worse or lasts more than 3 days
                      • redness or swelling is present in the painful area
                      • any new symptoms appear
                      • If pregnant or breastfeeding,
                        ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


Other



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


Directions



  • apply to affected area not more than 3 to 4 times daily
  • children under 2: ask a doctor
    • clean affected area
    • apply a small amount 1 to 3 times daily
    • may cover with a sterile bandage
      • do not take more than directed
      • the smallest effective dose should be used
      • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
      • If pain or fever does not respond to 1 tablet, 2 tablets may be used
      • do not exceed 6 tablets in 24 hours, unless directed by a doctor
      • children under 12 years: ask a doctor

Inactive Ingredients



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

petrolatum

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide


Triple Antibiotic Ointment



Drug Facts


Active Ingredient (In Each Gram)



Bacitracin zinc 400 units

Neomycin sulfate (3.5mg Neomycin)

Polymyxin B sulfate 5000 units


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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Pain Relief And Fever Reducer



Drug Facts


Active Ingredient (In Each Brown Tablet)



Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Other Information



  • TAMPER EVIDENT: DO NO USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat 40°C (104°F)
  • see label for expiration date and lot number
  • use by expiration date on package

Questions Or Comments?



1-833-BE-WELLY


Excursion First Aid Kit



EXTRA LARGE FIRST AID KIT TO COVER ANY BUMP, BRUISE OR SCRAPE.

Everything you need (and more) for when the unbeaten path gets the best of you.

Flexible fabric bandages that can move with your every move.

Durable metal case keeps it all together.

Cleansing wipes, tape and ibuprofen to help you get back out there.

Triple Antibiotic ointment helps prevent infection.

KIT INCLUDES

72 COUNT - STANDARD FABRIC BANDAGES

54 COUNT - SMALL FABRIC BANDAGES

6 COUNT - LARGE BANDAGES (3"x4")

18 COUNT - WATERPROOF BANDAGES

1 COUNT - ROLL OF TAPE

8 COUNT - NON STICK PADS

10 COUNT - CLEANSING WIPES

10 COUNT - BUTTERFLY STRIPS

10 COUNT - TRIPLE ANTIBIOTIC PACKETS

10 COUNT - HYDROCORTISONE PACKETS

1 VIAL - IBUPROFEN

Manufactured for: Welly Health PBC
Minneapolis, MN 55402
1-833-BE-WELLY

WellyTM www.GetWelly.com

Products of USA and China with globally sourced materials

Product not made with natural rubber latex

Sterile unless individual wrapper opened or damaged.

Patent Pending


Packaging




* Please review the disclaimer below.