Label: HYALOLEX HAND SANITIZER WITH LEMON AND ZINC- alcohol solution

  • NDC Code(s): 75540-536-02, 75540-536-08, 75540-536-16, 75540-536-28
  • Packager: India Globalization Capital
  • 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 19, 2023

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce germs on the skin

  • Warnings

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

  • Do not use

    • in or near the eyes. In case of contact rinse thoroughly with water
  • 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 if irritration occurs

  • 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

    • Wet hands with product ad briskly rub hands together until dry.
    • Supervise children under 6 years in use of this product
  • Other information

    • Store between 20C-25C (68F-77F)
    • May discolor certain fabrics
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Hyalolex Hand Sanitizer with Lemon and Zinc Safate and Paraben Free 70% Ethyl Alcohol Antimicrobial Kills Germs Package Label - Principal Display Panel

    59 mL Label236 mL Label472 mL Label3785 mL Label59 mL NDC: 75540-536-02

    236 mL NDC: 75540-536-08

    472 mL NDC: 75540-536-16

    3785 mL NDC: 75540-536-28

  • INGREDIENTS AND APPEARANCE
    HYALOLEX HAND SANITIZER WITH LEMON AND ZINC 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75540-536
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 2 mL  in 100 mL
    LEMON OIL (UNII: I9GRO824LL) 0.5 mL  in 100 mL
    ZINC ALUM (UNII: UGR874142R) 20 mg  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
    CARBOMER 980 (UNII: 4Q93RCW27E) 0.25 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 25 mL  in 100 mL
    XANTHAN GUM (UNII: TTV12P4NEE) 0.25 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75540-536-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    2NDC:75540-536-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    3NDC:75540-536-16472 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    4NDC:75540-536-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/30/2020
    Labeler - India Globalization Capital (364601877)
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