Label: LIFESHIELD HAND SANITIZER 70% ETOH- ethyl 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 August 20, 2020

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  • SPL UNCLASSIFIED SECTION

    This hand Sanitizer was manufactured according to the Federal Register 21 CFR 310, utilizing:

    a. USP/FCC grade Ethyl alcohol 99%

    b. Distilled/purified water

    c. Hydroxypropylcellulose (as Vegetable Cellulose)

    d. Glycerin USP/FCC grade

    e. Limonene (as fragrance)

    f. Aloe Vera extract

  • Active Ingredient(s)

    Ethyl alcohol 70%

  • Purpose

    Antiseptic, Hand Sanitizer

  • Uses

    Decreases bacteria on skin.

  • Warnings

    For external use only. Flammable, keep away from flames.

  • When using this product

    When using this product keep out of eyes. In case of contact, flush eyes with water.

  • Stop use

    Stop use and ask doctor if irritation and redness develop.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Rub hands thoroughly with product and allow to dry.
    • For children under 6, use only under adult supervision.

  • Other information

    • Store below 110ºF (43ºC).
    • May discolor certain fabrics or surfaces.

  • Inactive ingredients

    Inactive ingredients Distilled Water,
    Structured Silver, Vegetable Cellulose,
    Glycerin, Aloe Vera, Fragrance.

  • Questions

    Questions? Call 1-385-244-0470 Monday
    through Friday 8:30 AM to 5:00 PM MST.

  • 128 oz Packaging & Label - Principal Display Panel

    1 Gallon (3.78 L) 128 FL Oz - NDC: 75270-105-28

    128 oz Pump Bottle

    128 oz Label

  • 8 oz Packaging & Label - Principal Display Panel

    8 FL Oz (236 mL) - NDC: 75270-105-08

    8 oz bottle8 oz label

  • 16 oz Packaging & Label - Principal Display Panel

    16 FL Oz ( 473 mL) - NDC: 75270-105-16

    16 oz Pump Bottle

    16 oz label

  • 32 oz Packaging & Label - Principal Display Panel

    32 FL Oz ( 946 mL) - NDC: 75270-105-32

    32 oz bottle

    32 oz label

  • INGREDIENTS AND APPEARANCE
    LIFESHIELD HAND SANITIZER 70% ETOH 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75270-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70.7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.1 mL  in 100 mL
    ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.7 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 28.5 mL  in 100 mL
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) 0.01 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75270-105-283780 mL in 1 JUG; Type 0: Not a Combination Product06/28/2020
    2NDC:75270-105-08236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/28/2020
    3NDC:75270-105-32946 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/28/2020
    4NDC:75270-105-16473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/28/2020
    Labeler - LifeTech Pharma LLC. (057492812)
    Registrant - LifeTech Pharma LLC. (057492812)
    Establishment
    NameAddressID/FEIBusiness Operations
    LifeTech Pharma057492812manufacture(75270-105)
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