Label: GUARDRX UNSCENTED EXTRA STRENGTH- hand sanitizer liquid
GUARDRX LAVENDER PEPPERMINT EXTRA STRENGTH- hand sanitizer liquid
GUARDRX RED THYME EXTRA STRENGTH- hand sanitizer liquid

  • 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 May 4, 2020

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  • ACTIVE INGREDIENT

    Ethanol 70%

  • Purpose:

    Antiseptic

  • Uses:

    -For hand washing to decrease bacteria on skin.

    -Recommended for repeated use.

  • WARNINGS:

    -Flammable, keep away from children.

    -For external use only.

    -Do not use in eyes. If contact occurs, flush thoroughly with water.

    -Stop use and ask doctor if redness and irritation develop and persist for more than 72 hours.

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

  • Directions:

    Wet hands thoroughly with product and allow to dry without wiping.

    -Do not use other than directed.

  • STORAGE AND HANDLING

    Store at room temperature 20-25 °C (66-77 °F)

  • Inactive Ingredients:

    Aqua, Glycerin, Citrus Aurantium Dulcis (Orange) Peel Oil, Thymus Vulgaris (Red Thyme) Oil, Tocopherol.

  • ACTIVE INGREDIENT

    Ethanol 70%

  • Purpose:

    Antiseptic

  • Uses:

    -For hand washing to decrease bacteria on skin.

    -Recommended for repeated use.

  • WARNINGS:

    -Flammable, keep away from children.

    -For external use only.

    -Do not use in eyes. If contact occurs, flush thoroughly with water.

    -Stop use and ask doctor if redness and irritation develop and persist for more than 72 hours.

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

  • Directions:

    Wet hands thoroughly with product and allow to dry without wiping.

    -Do not use other than directed.

  • STORAGE AND HANDLING

    Store at room temperature 20-25 °C (66-77 °F)

  • Inactive Ingredients:

    Aqua, Glycerin, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Tocopherol.

  • ACTIVE INGREDIENT

    Ethanol 70%

  • Purpose:

    Antiseptic

  • Uses:

    -For hand washing to decrease bacteria on skin.

    -Recommended for repeated use.

  • WARNINGS:

    -Flammable, keep away from children.

    -For external use only.

    -Do not use in eyes. If contact occurs, flush thoroughly with water.

    -Stop use and ask doctor if redness and irritation develop and persist for more than 72 hours.

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

  • Directions:

    Wet hands thoroughly with product and allow to dry without wiping.

    -Do not use other than directed.

  • STORAGE AND HANDLING

    Store at room temperature 20-25 °C (66-77 °F)

  • Inactive Ingredients:

    Aqua, Glycerin, Tocopherol.

  • 59 mL NDC: 74306-133-02

    GuardRx Red Thyme Extra Strength 2oz 70

  • 118 mL NDC: 74306-133-04

    GuardRx Red Thyme Extra Strength 4oz 70

  • 236 mL NDC: 74306-133-08

    GuardRx Red Thyme Extra Strength 8oz 70

  • 59 mL NDC: 74306-134-02

    GuardRx Lavender Peppermint 2oz 70

  • 118 mL NDC: 74306-134-04

    GuardRx Lavender Peppermint 4oz 70

  • 236 mL NDC: 74306-134-08

    GuardRx Lavender Peppermint 8oz 70

  • 59 mL NDC: 74306-135-02

    GuardRx Unscented 2oz 70

  • 118 mL NDC: 74306-135-04

    GuardRx Unscented 4oz 70

  • 236 mL NDC: 74306-135-08

    GuardRx Unscented 8oz 70

  • INGREDIENTS AND APPEARANCE
    GUARDRX UNSCENTED EXTRA STRENGTH 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74306-135
    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)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74306-135-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
    2NDC:74306-135-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
    3NDC:74306-135-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/04/2020
    GUARDRX LAVENDER PEPPERMINT EXTRA STRENGTH 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74306-134
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74306-134-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
    2NDC:74306-134-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
    3NDC:74306-134-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/04/2020
    GUARDRX RED THYME EXTRA STRENGTH 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74306-133
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    THYME OIL (UNII: 2UK410MY6B)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74306-133-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
    2NDC:74306-133-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
    3NDC:74306-133-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/04/2020
    Labeler - GPS Associates (096942063)
    Registrant - GPS Associates, LLC (096942063)
    Establishment
    NameAddressID/FEIBusiness Operations
    GPS Associates096942063manufacture(74306-133, 74306-134, 74306-135)
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