Label: HAND SANITIZER gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     74034-006-01, 74034-006-02, 74034-006-03, 74034-006-04, view more
    74034-006-05, 74034-006-06, 74034-006-07, 74034-006-08, 74034-006-09, 74034-006-10, 74034-006-11
  • Packager: Sichuan Rejoy Essence Biotechnology Co., Ltd
  • 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 6, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 62% Purpose Antiseptic

  • Purpose

    Purpose Antiseptic

  • Uses

    Decreases Bacteria On Hands

  • WARNINGS

    For External Use Only

  • When using this product

    When using this product,do not use in or near the eyes.

  • 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

    /

  • Keep out of reach of children

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

  • Directions

    Squeeze onto hands and rub hands
    together briskly until dry. Do Not Store Above
    110°F Non-staining,may discolor certain fabrics

  • Other information

    Do Not Store Above
    110°F Non-staining,may discolor certain fabrics

  • Inactive ingredients

    Deionized Water,Carbomer,Triethanolamine,
    Aloe Barbadensis ,Ethanol,Glycerol,
    Propylene Glycol,Vitamin E.

  • Package Label - Principal Display Panel

    12

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74034-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74034-006-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    2NDC:74034-006-0220 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    3NDC:74034-006-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    4NDC:74034-006-0554 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    5NDC:74034-006-06100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    6NDC:74034-006-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    7NDC:74034-006-09500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    8NDC:74034-006-0450 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    9NDC:74034-006-07100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    10NDC:74034-006-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    11NDC:74034-006-1160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/17/2020
    Labeler - Sichuan Rejoy Essence Biotechnology Co., Ltd (407046287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sichuan Rejoy Essence Biotechnology Co., Ltd407046287manufacture(74034-006)
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