Label: WELLY HUMAN REPAIR KIT- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, hydrocortisone, alcohol kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 31, 2021

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

  • 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 other allergic reaction 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

  • 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

  • Instant Hand Sanitizer Gel

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • 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.

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

  • Directions

    • Wet hands & wrists thoroughly with product and allow to dry without wiping
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    FIRST AID TRAVEL KIT

    ASSORTED BANDAGES & OINTMENTS

    First aid kit sized for travel with everything you'll need and nothing you won't.

    • Flexible fabric bandages in two sizes and a few colors to cover cuts and scratches.
    • Hand Sanitizer helps keep hands clean when there's no sink in sight.
    • Triple Antibiotic ointment helps prevent infection.
    • 1% Hydrocortisone anti-itch ointment helps relieve skin irritation and rashes.

    Product not made with natural rubber latex.
    Bandages are sterile unless individual wrapper opened or damaged.

    Distributed by: Welly Health PBC
    Minneapolis, MN 55402
    1-833-BE-WELLY

    Recycle me!

    Welly TM www.GetWelly.com

    Human Repair Kit

    15 BANDAGES - 3/4 x 3 IN (1.9 x 7.6 CM)

    15 BANDAGES - 5/8 X 2 1/4 IN (1.6 X 5.7 CM)

    3 - TRIPLE ANTIBIOTIC 0.5g (1/57 OZ)

    3 - 1% HYDROCORTISONE 0.9g (1/32 OZ)

    6 - HAND SANITIZER 0.9g (1/32 OZ)

  • Packaging

    Rprcomp

    RprKit

  • INGREDIENTS AND APPEARANCE
    WELLY HUMAN REPAIR KIT 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, hydrocortisone, alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-130
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-130-231 in 1 KIT; Type 1: Convenience Kit of Co-Package03/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 POUCH 1.5 mL
    Part 23 POUCH 2.7 mL
    Part 36 POUCH 5.4 mL
    Part 1 of 3
    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 2 of 3
    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 3 of 3
    ANTISEPTIC 
    alcohol gel
    Product Information
    Item Code (Source)NDC:72663-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL666 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    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 finalpart333E02/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2019
    Labeler - Welly Health PBC (116766884)