Label: DISPOSABLE HAND SANITIZER- alcohol free hand sanitizer spray
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Contains inactivated NDC Code(s)
NDC Code(s): 55297-001-01 - Packager: Ningbo Salix Hygiene Products Co., Ltd.
- 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 August 6, 2020
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- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
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WARNINGS
1.Keep away from children.
2.For external use only.
3.Keep out of eyes. If contacts eyes, flush with water and call a doctor.
4.If irritation or rash: appears and persists, stops use and see a physician.
5.Do not store above 110°F(43° C)
6.If swallowed, get medical help or contact a Poison Control Center right away. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DISPOSABLE HAND SANITIZER
alcohol free hand sanitizer sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55297-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.65 g in 500 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55297-001-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/22/2020 Labeler - Ningbo Salix Hygiene Products Co., Ltd. (554541182) Establishment Name Address ID/FEI Business Operations Ningbo Salix Hygiene Products Co., Ltd. 554541182 manufacture(55297-001)