Label: MELLOW HAND SANITIZER 59ML ML315 01- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 54860-365-01 - Packager: Shenzhen Lantern Scicence 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 February 24, 2021
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
- Features
- Warning
- Inactive ingredients
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Directions
wet hands thoroughly with product and rub until dry without wiping.
For children under 6,use only under adult supervision.
Not recommended for infants.
- When using this product
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MELLOW HAND SANITIZER 59ML ML315 01
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54860-365 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.01 mL in 100 mL LEMON (UNII: 24RS0A988O) 0.1 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.26 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.08 mL in 100 mL WATER (UNII: 059QF0KO0R) 37.538 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL in 100 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 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:54860-365-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/14/2020 Labeler - Shenzhen Lantern Scicence Co.,Ltd. (421222423) Registrant - LANTERN HEALTH&BEAUTY LAB INC. (086860340) Establishment Name Address ID/FEI Business Operations Shenzhen Lantern Science Co.,Ltd. 421222423 manufacture(54860-365)
