Label: EVELINE CHARLES HAND SANITIZER- 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 June 5, 2020

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  • SPL UNCLASSIFIED SECTION

    Hand sanitize eliminates bacteria, germs and viruses. Skin softening formula features aloe vera and glycerin for hydration and protection.

  • Active Ingredient(s)

    Alcohol 72% w/w. Purpose: Antimicrobial

  • Purpose

    Hand Sanitizer.

  • Use

    Hand Sanitizer to kill harmful germs/bacteria/viruses. For use when soap and water are not available.

  • Warnings

    For external use only

    Flammability warning. Keep away from open flame and sources of heat
    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops.
    Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • 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

    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

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

  • Directions

    • Apply a small amount to the hands and spread evenly. Rub thoroughly into hands for at least 30 seconds. Allow to dry. For occasional and personal domestic use.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, carbomer, triethanolamine, aloe, purified water USP

  • PRINCIPAL DISPLAY PANEL

    60g label60g NDC: 76555-001-01

    240g NDC: 76555-001-02 240g label

    296g NDC: 76555-001-03 296g label

    500g NDC: 76555-001-04 500g label

    750g NDC: 76555-001-05

    1kg NDC:76555-001-06

    4kg NDC:76555-001-07 4 kg label1 kg label750 g label

  • INGREDIENTS AND APPEARANCE
    EVELINE CHARLES HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76555-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 g  in 100 g
    WATER (UNII: 059QF0KO0R) 25.15 g  in 100 g
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.55 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.25 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76555-001-0160 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
    2NDC:76555-001-02240 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
    3NDC:76555-001-03296 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
    4NDC:76555-001-04500 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
    5NDC:76555-001-05750 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
    6NDC:76555-001-061000 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
    7NDC:76555-001-074000 g in 1 JUG; Type 0: Not a Combination Product06/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/05/2020
    Labeler - Ec Labs Inc (205510751)
    Registrant - Ec Labs Inc (205510751)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ec Labs Inc205510751manufacture(76555-001) , pack(76555-001) , label(76555-001)
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