Label: BELUX LONDON HAND SANITIZER WITH ALOE VERA- 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 15, 2020

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  • Active Ingredient

    Alcohol 75% (v/v)

    1

  • Purpose

    Antiseptic

    2

  • Uses

    To help decrease germs on the skin that could cause disease.

    Recommended for repeated use.

    3

  • Warnings

    For external use only: hands

    Flammable, keep away from fire or flame. 4

  • When using this product:

    Avoid contact with broken skin.
    Do not inhale or ingest.
    Use with Caution if allergic.

    5

  • When using this product:

    Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    Avoid contact with broken skin.
    Do not inhale or ingest.
    Use with Caution if allergic.

    6

  • Stop use and ask a doctor if:

    Irritation or redness develops.
    Condition persists for more than 72 hours. 7

  • Keep out of reach by children:

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

    8

  • Directions

    Wet hands thoroughly without wiping until they dry.
    For children under 6, use only under adult supervision.

    Not recommended for infants.

    9

  • Other information

    After use, seal and tighten the cap and use product within the validity period.
    After use, seal and keep away from light and moisture.

    Store in a cool and dry place. Do not store above 37℃ (98.6℉) 10

  • Inactive ingredients

    Aloe, Carbomer 940, Glycerin, Trolamine, Water. 11

  • Package Label - Principal Display Panel

    100 mL NDC: 77084-001-01

    100 ml

    300 mL NDC: 77084-001-02

    300 ml

    500 mL NDC: 77084-001-03

    500 ml

  • INGREDIENTS AND APPEARANCE
    BELUX LONDON HAND SANITIZER WITH ALOE VERA 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77084-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.55 mL  in 100 mL
    ALOE (UNII: V5VD430YW9) 0.05 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 19 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 4 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77084-001-01100 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package06/15/2020
    2NDC:77084-001-02300 mL in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package06/15/2020
    3NDC:77084-001-03500 mL in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/15/2020
    Labeler - Belux UK Medical Technology Ltd (225838376)
    Registrant - Belux UK Medical Technology Ltd (225838376)
    Establishment
    NameAddressID/FEIBusiness Operations
    Belux UK Medical Technology Ltd225838376repack(77084-001) , relabel(77084-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Junchen Cosmetics Co., Ltd.402958582manufacture(77084-001) , pack(77084-001) , label(77084-001)
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