Label: PALMA HAND SANITIZER- ethyl 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 January 4, 2023

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

  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses 

    • hand sanitizer to decrease bacteria on the skin  • recommended for repeated use  • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame
    For external use only

    Do not use  • in children less than 2 months of age  • on open skin wounds

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if  • irritation and redness develop  • 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.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredients

    water, caprylic /capric triglyceride, avocado (Persea gratissima) oil, propylene glycol, glycerin, jojoba (Simmondsia chinensis) seed oil, peg-40 hydrogenated castor oil, polyacrylamide, c13-14 isoparaffin, laureth-7, acrylates / c10-30 alkyl acrylates crosspolymer, niacinamide, sodium hyaluronate, tocopheryl acetate, panthenol, gotu kola (Centella asiatica) root extract, triethanolamine, fragrance.

  • Questions? 1-516-535-5555

    You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    MOISTURIZING

    WITH AVOCADO OIL, JOJOBA OIL, VITAMIN B3 & B5

    PROTECT. HYDRATE. NOURISH.

    Distributed by:
    Palma De Salus, Inc
    320 Country Road, Suite 205
    Garden City, NY 11530, U.S.A


    Made in U.A.E.
    Designed in Los Angeles
    palmadesalus.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    PALMA HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81286-101
    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
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81286-101-101 in 1 CARTON07/26/2021
    1325 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/26/2021
    Labeler - UNITRADE FZE (864268417)