Label: HANDSOAP- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54837-002-01 - Packager: Campari Science & Technology (Suzhou) Co., Ltd.
- 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 April 15, 2020
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- 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
HANDSOAP
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54837-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 2.25 mg in 500 mL CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 1 mg in 500 mL Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERIN (UNII: PDC6A3C0OX) ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54837-002-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/15/2020 Labeler - Campari Science & Technology (Suzhou) Co., Ltd. (548374083) Establishment Name Address ID/FEI Business Operations Campari Science & Technology (Suzhou) Co., Ltd. 548374083 manufacture(54837-002)