SWEDISH DREAM SEA SALT HAND SANITIZER- ethyl alcohol formulation liquid 
Kala Corporation

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.

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Swedish Dream® Sea Salt Hand Sanitizer

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

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
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
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA) 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)

Revised: 1/2022
Document Id: d578f0b0-5e5d-1ef2-e053-2995a90ae7c1
Set id: aaa4fdad-2f07-dd39-e053-2a95a90a85bb
Version: 2
Effective Time: 20220113
 
Kala Corporation