Label: WE CLEAN HAND SANITIZER ROASTED MARSHMALLOW- alcohol liquid

  • 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 January 12, 2022

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

  • Active Ingredient(s)

    Alcohol 62% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Acrylates/C10-30 alkyl acrylate crosspolymer

    Ascorbyl palmitate

    Benzyl salicylate

    Blue 1 (CI 42090)

    Celluose

    Coumarin

    Deionized water

    Fragrance - Roasted Marshmallow

    Glycerin

    Hydroxypropyl methylcellulose

    Jojoba esters

    Lactose

    Red 33 (CI 17200)

    Tocopheryl acetate

    Triethanolamine

    Yellow 5 (CI 19140)

  • Package Label - Principal Display Panel

    250 mL NDC: 770006-031-01

    Label

  • INGREDIENTS AND APPEARANCE
    WE CLEAN HAND SANITIZER ROASTED MARSHMALLOW 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77006-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL58.36 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DRY BIOCELLULOSE (MW 2000000) (UNII: C8DF2GF8L2)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COUMARIN (UNII: A4VZ22K1WT)  
    WATER (UNII: 059QF0KO0R)  
    HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77006-031-01250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/26/2020
    Labeler - WeCool Toys (080480202)
    Registrant - WeCool Toys (080480202)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy545291775manufacture(77006-031) , label(77006-031) , pack(77006-031)