Label: ASPICARE- alcohol solution

  • 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 April 9, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria on the skin

  • Warnings

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

  • When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    irritation or rash appears or lasts

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry
    • Children under 6 years of age should be supervised when using ASPHICARE Hand sanitizer

  • Storage

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water (Aqua), Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Glycerin, Isosteareth-200 Linoleate, Fragrance Triethanolamine

  • Other Information

    Hand sanitizers provide a convenient alternative when hand washing with plain soap and water is unavailable. The Centers for Disease Control
    and Prevention advises that washing hands with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer. Hand sanitizers should not replace hand washing with soap and water. FDA conducts ongoing review of OTC antiseptic active ingredients to determine whether these ingredients are safe and effective for their intended uses.

  • Principal Display Panel

    NDC 70735-070-01

    AspiCare

    HAND SANITIZER

    KILLS 99% OF GERMS*

    Moisturizer Leaves Hands Smooth

    MADE IN USA

    1 FL OZ (30 mL)

    Label 1

    NDC 70735-070-02

    AspiCare

    HAND SANITIZER

    KILLS 99% OF GERMS*

    Moisturizer Leaves Hands Smooth

    MADE IN USA

    2 FL OZ (60 mL)

    Label 2

    NDC 70735-070-03

    AspiCare

    HAND SANITIZER

    KILLS 99% OF GERMS*

    Moisturizer Leaves Hands Smooth

    MADE IN USA

    3 FL OZ (89 mL)

    Label 3

    NDC 70735-070-04

    AspiCare

    HAND SANITIZER

    KILLS 99% OF GERMS*

    Moisturizer Leaves Hands Smooth

    MADE IN USA

    4 FL OZ (118 mL)

    Label 4

    NDC 70735-070-06

    AspiCare

    HAND SANITIZER

    KILLS 99% OF GERMS*

    Moisturizer Leaves Hands Smooth

    MADE IN USA

    6 FL OZ (177 mL)

    Label 6

    NDC 70735-070-08

    AspiCare

    HAND SANITIZER

    KILLS 99% OF GERMS*

    Moisturizer Leaves Hands Smooth

    MADE IN USA

    8 FL OZ (236 mL)

    Label 8

    NDC 70735-070-16

    AspiCare

    HAND SANITIZER

    KILLS 99% OF GERMS*

    Moisturizer Leaves Hands Smooth

    MADE IN USA

    16 FL OZ (473 mL)

    Label 16

    NDC 70735-070-32

    AspiCare

    HAND SANITIZER

    KILLS 99% OF GERMS*

    Moisturizer Leaves Hands Smooth

    MADE IN USA

    32 FL OZ (946 mL)

    Label 32

  • INGREDIENTS AND APPEARANCE
    ASPICARE 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70735-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70735-070-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2020
    2NDC:70735-070-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2020
    3NDC:70735-070-0389 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2020
    4NDC:70735-070-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2020
    5NDC:70735-070-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2020
    6NDC:70735-070-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2020
    7NDC:70735-070-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2020
    8NDC:70735-070-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/09/2020
    Labeler - American Private Label Products (051667474)
    Registrant - American Private Label Products (051667474)
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