Label: FLORANCE MORRIS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel
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NDC Code(s):
76612-180-10,
76612-180-12,
76612-180-25,
76612-180-37, view more76612-180-50
- Packager: Asimex International Llc
- Category: HUMAN OTC DRUG LABEL
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 May 4, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Use
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Warnings
For external use only: hands.
■Flammable ■Keep away from fire or flame
When using this product ■Keep out of eyes ■In case of contact with eyes, flush thoroughly with water ■Avoid contact with broken skin ■Do not inhale or ingest
Stop use and ask a doctor if ■Irritation or redness develops. ■Condition persists for more than 72 hours
- Directions
- Other information
- Inactive ingredients
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
FLORANCE MORRIS ANTISEPTIC HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76612-180 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 GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76612-180-12 125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/23/2020 2 NDC:76612-180-25 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/23/2020 3 NDC:76612-180-50 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/23/2020 4 NDC:76612-180-10 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/23/2020 5 NDC:76612-180-37 4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/23/2020 Labeler - Asimex International Llc (025004798) Establishment Name Address ID/FEI Business Operations Grupo Asimex de México, S.A. de C.V. 812962512 manufacture(76612-180)