Label: LIQUID HAND SOUP ECOSOL- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77993-004-01, 77993-004-02, 77993-004-03, 77993-004-04 - Packager: Ecosolutions, S. de R.L. 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 August 18, 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
LIQUID HAND SOUP ECOSOL
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77993-004 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 CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH) 0.07 mL in 100 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.5 mL in 100 mL WATER (UNII: 059QF0KO0R) 82.9 mL in 100 mL HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5) 0.5 mL in 100 mL COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 5 mL in 100 mL COCO GLUCOSIDE (UNII: ICS790225B) 5 mL in 100 mL POTASSIUM COCOATE (UNII: F8U72V8ZXP) 5 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77993-004-01 1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/30/2020 2 NDC:77993-004-02 5000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/30/2020 3 NDC:77993-004-03 20000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 4 NDC:77993-004-04 200000 mL in 1 CONTAINER; 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 - Ecosolutions, S. de R.L. de C.V. (814399275) Registrant - Ecosolutions, S. de R.L. de C.V. (814399275) Establishment Name Address ID/FEI Business Operations Ecosolutions, S. de R.L. de C.V. 814399275 manufacture(77993-004) , pack(77993-004) , label(77993-004)