Label: ANVI- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80201-200-01, 80201-200-02, 80201-200-03, 80201-200-04, view more80201-200-05, 80201-200-06, 80201-200-07, 80201-200-08, 80201-200-09, 80201-200-10, 80201-200-21 - Packager: Anvi LLC
- 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 November 17, 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(s)
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Warnings
For external use only. Keep out of ears, eyes or mouth. In case of contact with eyes, flush with water.
Stop use and ask doctor: If redness or irritation develops and persists for more than 72 hours.
Keep out of reach of children: If swallowed, get medical help or contact a Cpoison Control Center right away.
- Do not use
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Directions
Directions: Dispense an adequate amount into palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.
Other Information: Skin cells may shed naturally or by abrasion prior to four hours, exposing fresh, unprotected skin. Reapply as needed.
- Stop Use and ask a doctor
- Keep out of Reach of Children
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Directions for Use
Directions: Dispense an adequate amount into palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.
Other Information: Skin cells may shed naturally or by abrasion prior to four hours, exposing fresh, unprotected skin. Reapply as needed.
- Other information
- Inactive ingredients
- Questions-Information
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ANVI
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80201-200 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.2 g in 100 mL WATER (UNII: 059QF0KO0R) 99.67 g in 100 mL Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80201-200-01 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/26/2020 2 NDC:80201-200-02 108 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/26/2020 3 NDC:80201-200-04 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/26/2020 4 NDC:80201-200-03 167 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/26/2020 5 NDC:80201-200-05 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/26/2020 6 NDC:80201-200-06 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/26/2020 7 NDC:80201-200-07 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/26/2020 8 NDC:80201-200-09 208173 mL in 1 DRUM; Type 0: Not a Combination Product 08/26/2020 9 NDC:80201-200-10 1040864 mL in 1 CONTAINER; Type 0: Not a Combination Product 08/26/2020 10 NDC:80201-200-08 18925 mL in 1 PAIL; Type 0: Not a Combination Product 08/26/2020 11 NDC:80201-200-21 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/26/2020 Labeler - Anvi LLC (117619678) Registrant - Anvi LLC (117619678) Establishment Name Address ID/FEI Business Operations Anvi LLC 117619678 manufacture(80201-200)