Label: ALOE GEL- alcohol gel

  • NDC Code(s): 75594-071-01, 75594-071-03, 75594-071-04, 75594-071-05, view more
    75594-071-06, 75594-071-07, 75594-071-09, 75594-071-10, 75594-071-11, 75594-071-16, 75594-071-17, 75594-071-18, 75594-071-19, 75594-071-20, 75594-071-21, 75594-071-22, 75594-071-23, 75594-071-24, 75594-071-25
  • Packager: Commercial Beverage Concepts, LLC
  • This is a repackaged label.
  • Source NDC Code(s): 74221-004
  • 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 October 6, 2020

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

  • Active Ingredient(s)

    Alcohol 70% 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 ingest or inhale.

  • 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

    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

    Fragrance (Parfum), Glycerin, Isopropyl Myristate, Polyethylene Glycol/Acrylates Copolymer, Tocopheryl Acetate, Water

  • PRINCIPAL DISPLAY PANEL

    945.35mL NDC: 75594-071-09 AmeriClean 32oz Label

    1.89L NDC: 75594-071-10 AmeriClean 64oz Label

    3.78L NDC: 75594-071-11 AmeriClean Gallon Label

    237mL NDC: 75594-071-01 Modern Chem 8oz

    354mL NDC:75594-071-03 Modern Chem 16 oz

    946mL NDC: 75594-071-04 Modern Chem 32oz

    1.89L NDC: 75594-071-05 Modern Chem 64oz

    3.78L NDC: 75594-071-06 Modern Chemical Gallon

    208.198L NDC: 75594-071-07 Modern Chem Aloe Drum

    354mL NDC: 75594-071-16 Intergrity Aloe

    237mL NDC: 75594-071-17 Modern Chem 8oz Flip

    59ml NDC: 75594-071-18

    2oz Premium Label

    118ml NDC: 75594-071-19

    4oz Premium Label

    237ml NDC: 75594-071-20

    8oz Premium Label

    355ml NDC: 75594-071-21

    12oz Premium Label

    473ml NDC: 75594-071-22 16oz Premium Label

    946ml NDC: 75594-071-23

    32oz Premium Label1.89L NDC: 75594-071-24

    64oz Premium Label3.78L NDC: 75594-071-25

    128oz Premium Label

  • INGREDIENTS AND APPEARANCE
    ALOE GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75594-071(NDC:74221-004)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75594-071-090.94635 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    2NDC:75594-071-101.89 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    3NDC:75594-071-113.78 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    4NDC:75594-071-010.237 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    5NDC:75594-071-030.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    6NDC:75594-071-040.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    7NDC:75594-071-051.89 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    8NDC:75594-071-063.78 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    9NDC:75594-071-07208.198 L in 1 DRUM; Type 0: Not a Combination Product07/23/2020
    10NDC:75594-071-160.354 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    11NDC:75594-071-170.237 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/23/2020
    12NDC:75594-071-180.59 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/23/2020
    13NDC:75594-071-190.118 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/23/2020
    14NDC:75594-071-200.237 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    15NDC:75594-071-210.355 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    16NDC:75594-071-220.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    17NDC:75594-071-230.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    18NDC:75594-071-241.89 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    19NDC:75594-071-253.78 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/23/2020
    Labeler - Commercial Beverage Concepts, LLC (080925174)
    Establishment
    NameAddressID/FEIBusiness Operations
    Commercial Beverage Concepts, LLC080925174pack(75594-071) , repack(75594-071) , label(75594-071) , relabel(75594-071)