Label: WELLY FIRST AID KIT- hydrocortisone, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, ibuprofen kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 31, 2021

If you are a consumer or patient please visit this version.

  • 1% Hydrocortisone Cream

    Drug Facts

  • Active ingredient

    Hydrocortisone 1.0%

  • Purpose

    Anti-itch

  • 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.
  • 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

    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
  • Inactive ingredients

    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

  • Purpose

    First Aid Antibiotics

  • Uses

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

  • 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 allergic reactions develops
    • condition worsens or persists

    Keep out of reach of children. If ingested, 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
  • Inactive Ingredients

    petrolatum

  • Pain Relief and Fever Reducer

    Drug Facts

  • Active ingredient (in each brown tablet)

    Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • 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

    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.

    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.

  • Directions

    • 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
  • 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
  • Inactive ingredients

    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

  • Questions or comments?

    1-833-BE-WELLY

  • First Aid Kit

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

    Everything you need 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

    48 COUNT - STANDARD FABRIC BANDAGES

    30 COUNT - SMALL FABRIC BANDAGES

    3 COUNT - LARGE BANDAGES (3"x4")

    12 COUNT - WATERPROOF BANDAGES

    1 COUNT - ROLL OF TAPE

    5 COUNT - NON STICK PADS

    10 COUNT - CLEANSING WIPES

    10 COUNT - BUTTERFLY STRIPS

    5 COUNT - TRIPLE ANTIBIOTIC PACKETS

    5 COUNT - HYDROCORTISONE PACKETS

    1 VIAL - IBUPROFEN

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

    Recycle me!

    Welly TM 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

    Frst1

    Frst2

  • INGREDIENTS AND APPEARANCE
    WELLY FIRST AID KIT 
    hydrocortisone, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, ibuprofen kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-152
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-152-051 in 1 KIT; Type 0: Not a Combination Product04/06/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 15 POUCH 4.5 mL
    Part 25 POUCH 2.5 mL
    Part 31 BOTTLE 16 
    Part 410 POUCH 10 
    Part 1 of 4
    ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Item Code (Source)NDC:72663-580
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/25/2019
    Part 2 of 4
    ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Item Code (Source)NDC:72663-560
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN6 mg  in 1 mL
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 mL
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B0.77 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.5 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/25/2019
    Part 3 of 4
    PAIN RELIEF AND FEVER REDUCER 
    ibuprofen tablet
    Product Information
    Item Code (Source)NDC:72663-428
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/06/2020
    Part 4 of 4
    WELLY CLEANSING WIPE 
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/06/2020
    Labeler - Welly Health PBC (116766884)