Label: APOL HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80082-201-01 - Packager: ECOSEM 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 5, 2020
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
APOL HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80082-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 65 mL in 100 mL Inactive Ingredients Ingredient Name Strength CHINESE CINNAMON (UNII: WS4CQ062KM) TROLAMINE (UNII: 9O3K93S3TK) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMAECYPARIS LAWSONIANA WOOD OIL (UNII: 0H3D02DVNU) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80082-201-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/19/2020 Labeler - ECOSEM CO., LTD (695632865) Registrant - ECOSEM CO., LTD (695632865) Establishment Name Address ID/FEI Business Operations ECOSEM CO., LTD 695632865 manufacture(80082-201)