Label: ONE FOR ALL HAND SANITIZER- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80287-013-01, 80287-013-05, 80287-013-50 - Packager: Acatechol, Inc.
- 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 September 1, 2021
If you are a consumer or patient please visit this version.
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- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other Information
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Inactive Ingredients
USP Water, Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Mentha Piperita (Peppermint) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Caffeic Acid, N1-Hexadecyl-N1,N1,N2,N2-Tetramethyl-N2-(3-(Trihydroxysilyl)Propyl)ethane-1,2-Diaminium Dichloride, N1,N1,N2,N2-Tetramethyl-N1-Octadecyl-N2-(3-(Trihydroxysilyl)Propyl)ethane-1,2-Diaminium Dichloride, Octadecyl-dimethyl (3-Trihydroxysilyl Propyl) ammonium chloride, Citric Acid, Urea.
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SPL UNCLASSIFIED SECTION
Long-Lasting Nanodex™ Protection
Kills > 99.99% of Germs in Seconds
Gentle on Skin
Made in USA
We're putting science to work for the greater good.
Designed by a team of doctors and scientists to give you the best possible health advantage at home, at work...and everywhere you go.
Forms a long-lasting germicidal barrier that remains effective between hand-washings.
• FDA-compliant for Consumer & Health Care use
• With rejuvenating Vitamins C and E + Essential Oils
• Leaves hands feeling smooth and moisturized
• No alcohol, non-flammable
• No perfumes, sulfates or parabens
• No animal testing
Manufactured for: ACatechol, Inc.
10040 W Cheyenne Ave., Ste 170-65
Las Vegas NV 89129
OneForAllHands.com
- Packaging
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INGREDIENTS AND APPEARANCE
ONE FOR ALL HAND SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80287-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) TEA TREE OIL (UNII: VIF565UC2G) ROSEMARY OIL (UNII: 8LGU7VM393) PEPPERMINT OIL (UNII: AV092KU4JH) JOJOBA OIL (UNII: 724GKU717M) CAFFEIC ACID (UNII: U2S3A33KVM) N1-HEXADECYL-N1,N1,N2,N2-TETRAMETHYL-N2-(3-(TRIHYDROXYSILYL)PROPYL)ETHANE-1,2-DIAMINIUM DICHLORIDE (UNII: 58T3X2WUB9) N1,N1,N2,N2-TETRAMETHYL-N1-OCTADECYL-N2-(3-(TRIHYDROXYSILYL)PROPYL)ETHANE-1,2-DIAMINIUM DICHLORIDE (UNII: J4M68H8PMN) OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE (UNII: GLJ50K866T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) UREA (UNII: 8W8T17847W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80287-013-05 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/28/2020 2 NDC:80287-013-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/28/2020 3 NDC:80287-013-01 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/28/2020 Labeler - Acatechol, Inc. (104141956)