Label: WELLY SUPERHERO SUPPLIES KIT- alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hydrochloride, hydrocortisone 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

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  • 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

  • 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

  • Burn Gel

    Drug Facts

  • Active ingredient

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Uses

    Temporary pain relief for minor burns

  • Warnings

    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.

    Keep out of reach of children. If ingested contact a Poison Control Center directly

  • Directions

    • 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
  • Inactive ingredients

    aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

  • 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

  • SPL UNCLASSIFIED SECTION

    ASSORTED FIRST AID OINTMENTS

    ASSORTED SINGLE USE PACKETS

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

    Recycle me!

    Welly TM www.GetWelly.com

    Superhero Supplies

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

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

    9 - BURN GEL 0.9G (1/32 OZ)

    9 - 1% HYDROCORTISONE 0.9g (1/32 OZ)

  • Packaging

    SuperCmp

    SuperKt

  • INGREDIENTS AND APPEARANCE
    WELLY SUPERHERO SUPPLIES KIT 
    alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hydrochloride, hydrocortisone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-140
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-140-321 in 1 KIT; Type 0: Not a Combination Product03/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 19 POUCH 8.1 mL
    Part 29 POUCH 4.5 mL
    Part 39 POUCH 8.1 mL
    Part 49 POUCH 8.1 mL
    Part 1 of 4
    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
    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
    ANALGESIC 
    lidocaine hydrochloride gel
    Product Information
    Item Code (Source)NDC:72663-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    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 4 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2019
    Labeler - Welly Health PBC (116766884)
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