Label: HAND SANITIZER- hypochlorous acid solution
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Contains inactivated NDC Code(s)
NDC Code(s): 79841-001-05, 79841-001-10, 79841-001-45 - Packager: THAI WACOAL PUBLIC COMPANY LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated July 31, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
hypochlorous acid solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79841-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID 95 mg in 100 mL Inactive Ingredients Ingredient Name Strength GOLD (UNII: 79Y1949PYO) SODIUM CHLORIDE (UNII: 451W47IQ8X) MERCURY (UNII: FXS1BY2PGL) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79841-001-05 50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/31/2020 2 NDC:79841-001-10 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/31/2020 3 NDC:79841-001-45 450 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/31/2020 Labeler - THAI WACOAL PUBLIC COMPANY LIMITED (659934301) Establishment Name Address ID/FEI Business Operations IREAL PLUS (THAILAND) COMPANY LIMITED 671902247 manufacture(79841-001)