SWEDISH DREAM SEAWEED HAND SANITIZER- hand sanitizer spray 
SWEDISH DREAM SEA ASTER HAND SANITIZER- ethyl alcohol solution spray 
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® Seaweed and Sea Aster Hand Sanitizer

Drug Facts

Active Ingredient[s]

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

irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply on hands, rub until dry.

Other information:

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

Inactive Ingredients

Deionized water, Glycerine, Fragrance Oil

Seaweed Hand Sanitizer & Sea Aster Hand Sanitizer Label

Sea Aster Hand SanitizerSeaweed Hand Sanitizer

SWEDISH DREAM SEAWEED HAND SANITIZER 
hand sanitizer spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79655-607
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
WATER (UNII: 059QF0KO0R) 19.65 mL  in 59 mL
PARA-CRESOL (UNII: 1MXY2UM8NV) 0.08 mL  in 59 mL
ACETOPHENONE (UNII: RK493WHV10) 0.1 mL  in 59 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.8 mL  in 59 mL
BENZYL ACETATE (UNII: 0ECG3V79ZJ) 0.1 mL  in 59 mL
HEXYLENE GLYCOL (UNII: KEH0A3F75J) 0.1 mL  in 59 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79655-607-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/21/2020
SWEDISH DREAM SEA ASTER HAND SANITIZER 
ethyl alcohol solution spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79655-608
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
GLYCERIN (UNII: PDC6A3C0OX) 0.8 mL  in 59 mL
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) 0.01 mL  in 59 mL
COUMARIN (UNII: A4VZ22K1WT) 0.01 mL  in 59 mL
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA) 0.01 mL  in 59 mL
GALBANUM OIL (UNII: 211UF7M8N1) 0.2 mL  in 59 mL
METHYL BENZODIOXEPINONE (UNII: 0NQ136C313) 0.01 mL  in 59 mL
BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.01 mL  in 59 mL
CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E) 0.01 mL  in 59 mL
3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4) 0.01 mL  in 59 mL
ACETYL CEDRENE (UNII: X6I62755AK) 0.01 mL  in 59 mL
PHENYL ACETALDEHYDE DIMETHYL ACETAL (UNII: P8C94L4MUR) 0.01 mL  in 59 mL
2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE (UNII: 452GFV2AFS) 0.01 mL  in 59 mL
PHENYLACETALDEHYDE (UNII: U8J5PLW9MR) 0.01 mL  in 59 mL
ISOCYCLOCITRAL (UNII: 38HRF2I56T) 0.01 mL  in 59 mL
WATER (UNII: 059QF0KO0R) 20 mL  in 59 mL
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) 0.01 mL  in 59 mL
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) 0.2 mL  in 59 mL
8-(N-INDOLYL)-2,6-DIMETHYL-7-OCTEN-2-OL (UNII: 00NG926C95) 0.01 mL  in 59 mL
ISOEUGENYL BENZYL ETHER, (Z)- (UNII: 78Q46SZU33) 0.01 mL  in 59 mL
LINALYL ACETATE (UNII: 5K47SSQ51G) 0.01 mL  in 59 mL
BASIL OIL (UNII: Z129UMU8LE) 0.14 mL  in 59 mL
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.01 mL  in 59 mL
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.01 mL  in 59 mL
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F) 0.01 mL  in 59 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79655-608-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/02/2020
Labeler - Kala Corporation (623014826)
Registrant - Kala Corporation (623014826)
Establishment
NameAddressID/FEIBusiness Operations
Kala Corporation623014826manufacture(79655-607, 79655-608) , pack(79655-607, 79655-608) , label(79655-607, 79655-608)

Revised: 1/2022
Document Id: d578f58f-a805-df1e-e053-2a95a90a34de
Set id: b2ac79e8-826d-2186-e053-2995a90a9927
Version: 2
Effective Time: 20220113
 
Kala Corporation