Label: DIRE 70% GEL HAND SANITIZER - W- alcohol gel

  • 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 November 13, 2020

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

  • Active Ingredient(s)

    Alcohol 80% 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

    • on 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

    Water (Aqua), Glycerin, Hydrogen Peroxide, Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe, Lauryl Alcohol, Myristyl Alcohol, Fragrance (Parfum), PEG Dimethicone

  • Package Label - Principal Display Panel

    1 Gal3780 mL NDC: 74751-008-01

  • INGREDIENTS AND APPEARANCE
    DIRE 70% GEL HAND SANITIZER - W 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74751-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70.6646 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MYRISTYL LACTATE (UNII: 1D822OC34X) 0.3895 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0012 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.5177 mL  in 100 mL
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) 0.0924 mL  in 100 mL
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 0.2087 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.1284 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.2805 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 0.0215 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74751-008-013780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2020
    2NDC:74751-008-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2020
    3NDC:74751-008-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2020
    4NDC:74751-008-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2020
    Labeler - Applichem, Inc (039829528)