Label: ELEGANT MAXIMUM FRESH HAND SANITIZER- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80309-002-01, 80309-002-02, 80309-002-03, 80309-002-04 - Packager: EPOCH Cosmetics and Toiletries Industries LLC
- 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 28, 2020
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
ELEGANT MAXIMUM FRESH HAND SANITIZER
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80309-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80309-002-04 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:80309-002-03 750 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 3 NDC:80309-002-02 250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/30/2020 4 NDC:80309-002-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - EPOCH Cosmetics and Toiletries Industries LLC (561196517) Establishment Name Address ID/FEI Business Operations EPOCH Cosmetics and Toiletries Industries LLC 561196517 manufacture(80309-002)