Label: HAND SANITIZER- benzalkonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 77824-002-01 - Packager: Betone, S.A de C.V.
- 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 15, 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
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - 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
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77824-002 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.03 mL in 100 mL METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.13 mL in 100 mL ABRONIA FRAGRANS FLOWER (UNII: XAV1S68QBA) 0.1 mL in 100 mL DIMETHICONE PEG-7 PANTHENYL PHOSPHATE (12 PANTHENOL) (UNII: 7MA9F33W92) 0.2 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1 mL in 100 mL ALOE VERA FLOWER (UNII: 575DY8C1ER) 0.0004 mL in 100 mL WATER (UNII: 059QF0KO0R) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) 0.13 mL in 100 mL POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.15 mL in 100 mL PEG-70 LANOLIN (UNII: 687SBQ855W) 0.1 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77824-002-01 150 mL in 1 POUCH; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Betone, S.A de C.V. (813262755) Establishment Name Address ID/FEI Business Operations Betone, S.A de C.V. 813262755 manufacture(77824-002) , pack(77824-002) , label(77824-002)
