Label: PFA STRONGHOLD SANITIZING HANDLOTION MINT- alcohol lotion
- NDC Code(s): 80969-006-01
- Packager: STRONGHOLD TRADING LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 25, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
- Other information
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Inactive ingredients
Water, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, PEG-60 Hydrogenated Castor Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate, Ammonium Polyacryloyldimethyl Taurate, Caprylic/Capric Triglyceride, Mentha Rotundifolia Leaf Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Melissa Officinalis Leaf Extract, Cymbopogon Schoenanthus Extract, Centella Asiatica Extract, Polysorbate 80, Mentha Piperita (Peppermint) Oil, Limonene
- Package Label
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INGREDIENTS AND APPEARANCE
PFA STRONGHOLD SANITIZING HANDLOTION MINT
alcohol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80969-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U) PEPPERMINT OIL (UNII: AV092KU4JH) LIMONENE, (+)- (UNII: GFD7C86Q1W) SHEA BUTTER (UNII: K49155WL9Y) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 100 STEARATE (UNII: YD01N1999R) AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80969-006-01 2 mL in 1 POUCH; Type 0: Not a Combination Product 11/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/26/2021 Labeler - STRONGHOLD TRADING LLC (117694134) Registrant - S-ONE PHARMACEUTICAL INC (694626932) Establishment Name Address ID/FEI Business Operations S-ONE PHARMACEUTICAL INC 694626932 manufacture(80969-006)