Label: ELEGANT MAXIMUM FRESH HAND SANITIZER- isopropyl alcohol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 90012-003-01, 90012-003-02, 90012-003-03 - Packager: Porto Pavino 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 21, 2020
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- 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 sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:90012-003 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) ETHYLENE GLYCOL (UNII: FC72KVT52F) PROPANE (UNII: T75W9911L6) BUTANE (UNII: 6LV4FOR43R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:90012-003-03 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:90012-003-02 60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/30/2020 3 NDC:90012-003-01 20 mL in 1 BOTTLE, SPRAY; 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 - Porto Pavino LLC (966266434) Establishment Name Address ID/FEI Business Operations EPOCH Cosmetics and Toiletries Industries LLC 561196517 manufacture(90012-003)