Label: MELLOW HAND SANITIZER 59ML 01- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54860-329-01 - Packager: Shenzhen Lantern Science 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 September 2, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Warning
- Inactive ingredients
- Directions
- When using this product
- Keep out of reach of children
- Stop use and ask a doctor
- Use
- OTHER SAFETY INFORMATION
- dosage
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MELLOW HAND SANITIZER 59ML 01
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54860-329 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 mL Inactive Ingredients Ingredient Name Strength LEMON (UNII: 24RS0A988O) 0.05 mL in 100 mL POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.15 mL in 100 mL WATER (UNII: 059QF0KO0R) 98.3 mL in 100 mL EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.1 mL in 100 mL HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 0.9 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.4 mL in 100 mL Product Characteristics Color white (transparant) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54860-329-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/03/2020 Labeler - Shenzhen Lantern Science Co.,Ltd. (421222423) Registrant - Lantern Beauty America,INC. (117371139) Establishment Name Address ID/FEI Business Operations Shenzhen Lantern Science Co., Ltd. 421222423 manufacture(54860-329)
