Label: HYGIENE OF SWEDEN- pocket spray aerosol, spray
- NDC Code(s): 81274-001-01
- Packager: Hygiene of Sweden AB
- 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 March 18, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYGIENE OF SWEDEN
pocket spray aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81274-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 9.9 mg in 100 mL Inactive Ingredients Ingredient Name Strength LACTIC ACID (UNII: 33X04XA5AT) 0.03 mL in 100 mL CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) (UNII: 5GV09YMO52) 0.02 mL in 100 mL POLYETHYLENIMINE HYDROCHLORIDE (20000 MW) (UNII: R1Q64CR5FF) 0.01 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.25 mL in 100 mL DEXPANTHENOL (UNII: 1O6C93RI7Z) 0.01 mL in 100 mL WATER (UNII: 059QF0KO0R) 99.48 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81274-001-01 20 mL in 1 BOTTLE, SPRAY; Type 6: Drug/Biologic Combination 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2020 Labeler - Hygiene of Sweden AB (353008228) Registrant - Hygiene of Sweden AB (353008228) Establishment Name Address ID/FEI Business Operations Hygiene of Sweden USA LLC 117779651 label(81274-001) Establishment Name Address ID/FEI Business Operations Hygiene of Sweden AB 353008228 manufacture(81274-001)
