Label: CLASSY HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74004-060-01 - Packager: Ester 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 November 11, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
Warnings:
Flammable, Keep away from fire or flame
For external use onlyWhen using this product do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or redness develops.
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- Other Information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLASSY HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74004-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 350 g in 500 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) EDETOL (UNII: Q4R969U9FR) ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74004-060-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/01/2020 Labeler - Ester Co., Ltd. (688425766) Registrant - Ester Co., Ltd. (688425766) Establishment Name Address ID/FEI Business Operations Ester Co., Ltd. 688425766 manufacture(74004-060)