Label: HAND SANITIZER- alcohol 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 October 11, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    For handwashing to decrease bacteria on the skin recommended for repeated use

  • Warnings

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

  • Do not use

    • in the eyes. In case of contact rinse eyes thoroughly with water.
    • Keep out of reach of children. If swallowed, get medical help and contact a Poison Control Center right away.
    • Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
  • 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 and ask a doctor if irritation and redness develop and persist for more than 72 hours.

  • 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 enough sanitizer into your palm
    • Rub hands together, palm to palm
    • Keep rubbing for 20 seconds
    • Rub hands until dry
    • P
  • Other information

    • Store below 110F (43C)
  • Inactive ingredients

    distilled water, glycerine, carbomer 940, tween 20, azadirachtae indicae oil, aloe vera, essential oil, basil oil, rosemary, vitamin e.

  • Package Label - Principal Display Panel

    30ml NDC: 76699-100-03

    76699-100-03

    76699-100-03-3

    50mL NDC: 76699-100-04

    76699-100-04

    76699-100-04-3

    60mL NDC: 76699-100-09

    76699-100-09-3

    76699-100-09-2

    100 mL NDC: 76699-100-01

    7669-100-01-4

    76699-100-01-2

    300 mL NDC: 76699-100-02

    76699-100-02

    76699-100-02-2

    500 mL NDC: 76699-100-05

    76699-100-05

    76699-100-05-3

    1000 mL NDC: 76699-100-06

    76699-100-06

    76699-100-06-3

    3.85L NDC: 76699-100-07

    76699-100-07-2

    76699-100-07

    208L NDC: 76699-100-08

    76699-100-08

    76699-100-08-3

    60mL: NDC 76699-100-09

    76699-100-09

    76699-100-09-3

    250mL: NDC 76699-100-10

    76699-100-10

    1.5mL: NDC 76699-100-13

    76699-100-13-3

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76699-100
    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) 1 mL  in 100 mL
    CAJUPUT OIL (UNII: J3TO6BUQ37) 0.5 mL  in 100 mL
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) 0.5 mL  in 100 mL
    ROSEMARY (UNII: IJ67X351P9) 1.45 mL  in 100 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.1 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.6 mL  in 100 mL
    BASIL OIL (UNII: Z129UMU8LE) 1.45 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 22.5 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76699-100-05500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
    2NDC:76699-100-02300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
    3NDC:76699-100-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2020
    4NDC:76699-100-061000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
    5NDC:76699-100-08208000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
    6NDC:76699-100-073850 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
    7NDC:76699-100-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2020
    8NDC:76699-100-0450 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2020
    9NDC:76699-100-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2020
    10NDC:76699-100-10250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2020
    11NDC:76699-100-115000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
    12NDC:76699-100-131.5 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/15/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/15/2020
    Labeler - SECCO HCSP GROUP JSC (555662957)
    Registrant - SECCO HCSP GROUP JSC (555662957)
    Establishment
    NameAddressID/FEIBusiness Operations
    SECCO HCSP GROUP JSC555662957manufacture(76699-100)
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