Label: MELLOW 59ML INSTANT HAND SANITIZER 01- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54860-392-01 - 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 April 11, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Medicical Ingredient
- Features
- Warning
- Non-Medicinal
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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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MELLOW 59ML INSTANT HAND SANITIZER 01
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54860-392 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL in 100 mL ALOE (UNII: V5VD430YW9) 0.15 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.00006 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.26 mL in 100 mL WATER (UNII: 059QF0KO0R) 36.307916 mL in 100 mL ISOPROPYL ALCOHOL (UNII: ND2M416302) 0.5 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.08 mL in 100 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.000024 mL in 100 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.001 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.1 mL in 100 mL Product Characteristics Color green Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54860-392-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/11/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/11/2022 Labeler - Shenzhen Lantern Science Co.,Ltd (421222423) Registrant - LANTERN HEALTH&BEAUTY LAB INC (086860340) Establishment Name Address ID/FEI Business Operations Shenzhen Lantern Science Co.,Ltd. 421222423 manufacture(54860-392)