Label: SWEDISH DREAM SEA SALT HAND SANITIZER- ethyl alcohol formulation 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 July 8, 2020

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  • Active Ingredient

    Ethyl Alcohol 65%

  • Purpose

    Antiseptic

  • Uses

    Sanitizer to help reduce bacteria on skin. For use when soap and water not available.

  • Warnings

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

  • When using this product

    Keep out of eyes. In case of contact, flush thoroughly with water.

  • Stop use and ask a doctor if

  • Keep out of reach of children

    If swallowed get medical help or contact a poison control center right away.

  • Directions:

    Apply on hands and rub until dry.

  • Other Information

    Store between 15-30C(59-86F) - Avoid freezing and excess heat over 40C(104F)

  • Inactive Ingredients

    Deionized Water, Glycerine, Sea Salt Essence (Fragrance Oil)

  • Sea Salt Hand Sanitizer Label

    Sea Salt Hand Sanitizer - Made in the Ocean State

  • INGREDIENTS AND APPEARANCE
    SWEDISH DREAM SEA SALT HAND SANITIZER 
    ethyl alcohol formulation liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79655-606
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL38.35 mL  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA) 0.05 mL  in 59 mL
    LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.05 mL  in 59 mL
    WATER (UNII: 059QF0KO0R) 18.88 mL  in 59 mL
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) 0.05 mL  in 59 mL
    LINALYL ACETATE (UNII: 5K47SSQ51G) 0.04 mL  in 59 mL
    ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ) 0.01 mL  in 59 mL
    .ALPHA.-AMYLCINNAMALDEHYDE DIMETHYL ACETAL (UNII: M2X8F8W2U8) 0.03 mL  in 59 mL
    METHYL BENZODIOXEPINONE (UNII: 0NQ136C313) 0.05 mL  in 59 mL
    8-(N-INDOLYL)-2,6-DIMETHYL-7-OCTEN-2-OL (UNII: 00NG926C95) 0.1 mL  in 59 mL
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) 0.05 mL  in 59 mL
    CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E) 0.05 mL  in 59 mL
    2,6,10-TRIMETHYL-9-UNDECENAL (UNII: JNM5JFE28J) 0.05 mL  in 59 mL
    2-METHYLUNDECANAL (UNII: S94QNS2VY5) 0.05 mL  in 59 mL
    2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F) 0.05 mL  in 59 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.885 mL  in 59 mL
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) 0.05 mL  in 59 mL
    .ALPHA.-TERPINEOL (UNII: 21334LVV8W) 0.05 mL  in 59 mL
    BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.05 mL  in 59 mL
    ISOAMYL SALICYLATE (UNII: M25E4ZMR0N) 0.05 mL  in 59 mL
    3-HEXENYL SALICYLATE, CIS- (UNII: C78Y9OR6YH) 0.05 mL  in 59 mL
    METHYL 2-NONYNOATE (UNII: 8RN66UR57V) 0.005 mL  in 59 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79655-606-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/08/2020
    Labeler - Kala Corporation (623014826)
    Registrant - Kala Corporation (623014826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kala Corporation623014826manufacture(79655-606)