Label: ONE STEP- 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 February 1, 2019

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

View All Sections
  • ACTIVE INGREDIENT

    Ethyl Alcohol 70% v/v

  • Uses

    Hand Sanitizer to help reduce bacteria on the skin

  • Keep out of reach of children

    Keep out of reach of children

  • Directions

    • place enough product in your palm to thoroughly cover your

    hands and rub hands together until dry.

    • children under 6 years should be supervised when using this

    product.

  • WARNINGS

    Flammable. Keep away from source of heat, fire or flame.

    For external use only.

    When using this product avoid contact with eyes. If contact

    occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or redness develops and

    lasts.

    Keep out of reach of children. If swallowed, get medical help

    or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    • place enough product in your palm to thoroughly cover your

    hands and rub hands together until dry.

    • children under 6 years should be supervised when using this

    product.

  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Ext. Violet 2 (CI 60730), Fragrance (Parfum), Polysorbate 20, Tetrahydroxypropyl Ethylenediamine, Water (Aqua).

  • packaging label

    473 ml label60 ml label236 ml label

  • INGREDIENTS AND APPEARANCE
    ONE STEP 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60742-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    EDETOL (UNII: Q4R969U9FR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60742-300-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
    2NDC:60742-300-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
    3NDC:60742-300-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/01/2019
    Labeler - Belvedere International Inc. (247836356)
    Registrant - BELVEDERE INTERNATIONAL INC. (247836356)
    Establishment
    NameAddressID/FEIBusiness Operations
    Belvedere International Inc.247836356manufacture(60742-300)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!