Label: CHOICE HAND SANITIZE- ethyl alcohol gel

  • NDC Code(s): 58575-183-01, 58575-183-02
  • Packager: Inopak. 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 February 19, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • 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. Children should be supervised by an adult when using this product.

  • Usage

    Uses

    • To decrease bacteria on the skin that potentially can cause disease
    • Recommended for repeated use
  • Warnings

    Warnings

    • Flammable, keep away from heat or flame.
    • For external use only.
  • Other Information

    Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water

    May discolor certain fabrics and surfaces.

  • Stop Usage

    Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

  • Administration

    Directions

    • Apply sufficient amount of product to your palm to cover both hands.
    • Rub until dry.
  • Inactive Ingredients

    Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

  • Choice Box Container

    Drug Facts

    Active Ingredient                             Purpose

    Ethyl Alcohol 70% v/v ……………Antiseptic

    Uses

    • To decrease bacteria on the skin that potentially can cause disease
    • Recommended for repeated use

    Warnings

    • Flammable, keep away from heat or flame.
    • For external use only.

    Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

    Keep out of reach of children. If swallowed. Get medical help or contact a Poison Control Center right away. Children should be supervised by an adult when using this product.

    Directions

    • Apply sufficient amount of product to your palm to cover both hands.
    • Rub until dry.

    Other Information

    May discolor certain fabrics and surfaces.

    Inactive Ingredients

    Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, FD&C Blue 1, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

    Choice

    HAND SANITIZING GEL

    Aloe Ver

      And

    Vitamin E

    Instant

    Waterless

    Contains

    Moisturizers

    PN 5025-404UV-CH

    800m 

    Hand sanitizing gel

    • Contains Aloe Vera and Vitamin E
    • Instant waterless with moisturizers
    • Produced in an FDA registered facility
    • cGMP facility
    • Dries quickly leaving the skin feeling soothed and moisturized

    Kills

    99.9% of

    Germs

    MADE IN THE USA

    Choice

    Dispenser Loading Instructions

    Section 1Section 2Section 3Section 4

          Section 1                                 Section 2                           Section 3                           Section 4

    Choice Box

  • Choice Case

                                                                                    5025-CH-CS         Rev. 1.0

    Choice™

    HAND SANITIZING GEL                   Kills 99.9% of Germs

    Instant Waterless                             Aloe Ver and Vitamin E

    Contains Moisturizers

    MADE IN THE USA                           5025-404UV-CH

                                                                    12/800 ML UV                   040232 65077 2

    Choice Case

  • INGREDIENTS AND APPEARANCE
    CHOICE  HAND SANITIZE
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-183
    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 (UNII: V5VD430YW9)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58575-183-01800 mL in 1 POUCH; Type 0: Not a Combination Product01/02/202007/11/2024
    2NDC:58575-183-029600 mL in 1 CASE; Type 0: Not a Combination Product01/02/202007/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/02/202007/11/2024
    Labeler - Inopak. Ltd (194718243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inopak. Ltd194718243manufacture(58575-183)