SWEDISH DREAM SEA SALT HAND SANITIZER- ethyl alcohol formulation liquid

Swedish Dream Sea Salt Hand Sanitizer by

Drug Labeling and Warnings

Swedish Dream Sea Salt Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kala Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SWEDISH DREAM SEA SALT HAND SANITIZER 
ethyl alcohol formulation liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79655-606
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	38.35 mL  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79655-606-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/08/2020

Labeler - Kala Corporation (623014826)

Registrant - Kala Corporation (623014826)

Establishment
Name	Address	ID/FEI	Business Operations
Kala Corporation		623014826	manufacture(79655-606)