Label: SWEDISH DREAM SEA SALT HAND SANITIZER- ethyl alcohol formulation liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 79655-606-01 - 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)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions:
- Other Information
- Inactive Ingredients
- Sea Salt Hand Sanitizer Label
-
INGREDIENTS AND APPEARANCE
SWEDISH DREAM SEA SALT HAND SANITIZER
ethyl alcohol formulation liquidProduct 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)