Label: ETHYL ALCOHOL gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73764-002-01, 73764-002-02, 73764-002-03, 73764-002-04, view more73764-002-05 - Packager: Marine Essence Biosciences Corporation of USA
- 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 June 3, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- WHEN USING
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INSTRUCTIONS FOR USE
- OTHER SAFETY INFORMATION
- DOSAGE FORMS & STRENGTHS
- WARNINGS
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ETHYL ALCOHOL
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73764-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER 940 (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73764-002-01 500 mL in 1 BOTTLE, PUMP; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 03/23/2020 2 NDC:73764-002-02 236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/23/2020 3 NDC:73764-002-03 177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/23/2020 4 NDC:73764-002-04 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/23/2020 5 NDC:73764-002-05 250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/23/2020 Labeler - Marine Essence Biosciences Corporation of USA (116587566) Establishment Name Address ID/FEI Business Operations Marine Essence Biosciences Corporation of USA 116587566 manufacture(73764-002) , pack(73764-002) , label(73764-002)