Label: SWEDISH DREAM SEAWEED HAND SANITIZER- hand sanitizer spray
SWEDISH DREAM SEA ASTER HAND SANITIZER- ethyl alcohol solution spray
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Contains inactivated NDC Code(s)
NDC Code(s): 79655-607-01, 79655-608-01 - Packager: Kala Corporation
- 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 13, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
- Directions
- Other information:
- Inactive Ingredients
- Seaweed Hand Sanitizer & Sea Aster Hand Sanitizer Label
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INGREDIENTS AND APPEARANCE
SWEDISH DREAM SEAWEED HAND SANITIZER
hand sanitizer sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79655-607 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:79655-607-01 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/21/2020 SWEDISH DREAM SEA ASTER HAND SANITIZER
ethyl alcohol solution sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79655-608 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:79655-608-01 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/02/2020 Labeler - Kala Corporation (623014826) Registrant - Kala Corporation (623014826) Establishment Name Address ID/FEI Business Operations Kala Corporation 623014826 manufacture(79655-607, 79655-608) , pack(79655-607, 79655-608) , label(79655-607, 79655-608)
