Label: DERMAGEL HAND SANITIZING- 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 May 3, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol 70% v/v

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • To decrease bacteria on the skin.
    • Recommended for repeated use.
  • WARNINGS

    Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    When using this product keep out of eyes. In case of eye contact, rinse eyes with water.

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally to hands to cover all surfaces
    • Rub hands together until dry.
    • Supervise children under 6 years old.
    • Not recommended for infants.
  • STORAGE AND HANDLING

    Other information

    • Store between 15 - 30°C (59-86°F)
    • May discolor certain fabrics and surfaces.
  • INACTIVE INGREDIENT

    Inactive ingredients Water, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Triethanolamine, Alpha-tocopheryl Acetate (Vitamin E), Aloe Barbadensis Leaf Juice, FD&C Yellow 5, FD&C Blue 1.

  • SPL UNCLASSIFIED SECTION

    Inopak LTD.

    Ringwood, NJ 07456

    1-800-762-7725 • www.inopak.com

  • PRINCIPAL DISPLAY PANEL

    DermaGel®

    HAND SANITIZING GEL with moisturizers

    70% Alcohol with ALOE VERA & VITAMIN E

    33.8 fl. oz. (1000 mL)

    DermaGel Green-1000mL

  • INGREDIENTS AND APPEARANCE
    DERMAGEL  HAND SANITIZING
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-130
    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
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58575-130-0260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/01/1990
    2NDC:58575-130-04118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/01/1990
    3NDC:58575-130-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/1990
    4NDC:58575-130-18532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/1990
    5NDC:58575-130-373785 mL in 1 JUG; Type 0: Not a Combination Product09/01/1990
    6NDC:58575-130-65650 mL in 1 BAG; Type 0: Not a Combination Product09/01/1990
    7NDC:58575-130-80800 mL in 1 BAG; Type 0: Not a Combination Product09/01/199002/01/2020
    8NDC:58575-130-101000 mL in 1 BAG; Type 0: Not a Combination Product09/01/199002/01/2020
    9NDC:58575-130-81800 mL in 1 POUCH; Type 0: Not a Combination Product09/01/1990
    10NDC:58575-130-821000 mL in 1 POUCH; Type 0: Not a Combination Product09/01/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/1990
    Labeler - Inopak. Ltd (194718243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inopak. Ltd194718243manufacture(58575-130)
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