Label: HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 75360-1125-1, 75360-1125-2, 75360-1125-3, 75360-1125-4, view more
    75360-1125-5, 75360-1125-6, 75360-1125-7
  • Packager: Hemani International
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • SPL UNCLASSIFIED SECTION

    The hand sanitizer is manufactured using only the following ingredients in the preparation of the product (percentage in final product formulation):

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v))
    2. Sterile distilled water or boiled cold water.
    3. Glycerol (5% v/v).
    4. Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked)(1.5% v/v).
    5. Propylene Glycol (1% v/v).
    6. Fragrance (Dimethyl Anthranilate) (0.5% v/v).
    7. Triethanolamine (0.15% v/v).
    8. Dexpanthenol (Panthenol) (0.10% v/v).
    9. Aloe Barbadensis Leaf Juice Powder (0.05% v/v).
    10. Beads (Mannitol, Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Pigment Green 7 (CI 74260) (0.02% v/v).
    11. Blue 1 (CI 42090) (0.005% v/v).

    The firm does not add other active or inactive ingredients besides listed above.

  • Active Ingredient(s)

    Ethyl Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • 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 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 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

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • 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

    water (aqua), glycerin (glycerol), Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked), propylene glycol, Fragrance (Dimethyl Anthranilate), Triethanolamine, Dexpanthenol (Panthenol), Aloe Barbadensis Leaf Juice Powder, Beads [(Mannitol, Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Pigment Green 7 (CI 74260)], Blue 1 (CI 42090)

  • Package Label - Principal Display Panel

    ​50 mL NDC: 75360-1125-1

    65 mL NDC: 75360-1125-2

    100 mL NDC: 75360-1125-3

    250 mL NDC: 75360-1125-4

    1 L NDC: 75360-1125-5

    500 mL NDC: 75360-1125-6

    50 mL Label65 mL Label100 mL Label250 mL Label1L Label

    500mL Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75360-1125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.005 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.15 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 mL  in 100 mL
    DIMETHYL ANTHRANILATE (UNII: 5Z37T562P9) 0.5 mL  in 100 mL
    MANNITOL (UNII: 3OWL53L36A)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    PIGMENT GREEN 7 (UNII: BPO9294G4W)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z) 0.1 mL  in 100 mL
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) 1.5 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mL  in 100 mL
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GLYCERIN (UNII: PDC6A3C0OX) 5 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 11.68 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75360-1125-150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    2NDC:75360-1125-265 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    3NDC:75360-1125-4250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    4NDC:75360-1125-51000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    5NDC:75360-1125-3100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    6NDC:75360-1125-6500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    7NDC:75360-1125-7400 mL in 1 BAG; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/01/2020
    Labeler - Hemani International (645581294)
    Registrant - Hemani International (645581294)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hemani International645581294manufacture(75360-1125)
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