Label: AMERIWIPES DISINFECTANT WIPES- benzalkonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 78804-215-00, 78804-215-55, 78804-215-56 - Packager: Allure Chemicals LP
- 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 September 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Use[s]
- Precautionary Statements
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SPL UNCLASSIFIED SECTION
Use Ameriwipes on: Bathroom fixtures, countertops, high touch surfaces, patient monitoring equipment, tables, beside tables, computer keyboards, desks, equipment surfaces, faucets, IV stands, light switches, toys** (** rinse toys with clean, potable water after disinfecting), telephones, toilet bowl surfaces gym and more.
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Directions
Wipe hard, nonporous surface with wipe until surface is visibly wet. Use enough wipes to keep surfaces visibly wet for 2 minutes. Allow surface to remain wet for 2 minutes. If surfaces are extremely dirty, clean first with another wipe before disinfecting. Discard used wipe in trash. Do not flush in toilet.
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
AMERIWIPES DISINFECTANT WIPES
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78804-215 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.4 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) C20-40 PARETH-3 (UNII: 68103A23TQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78804-215-56 75 in 1 BOX 06/09/2020 1 0.8 g in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:78804-215-55 100 in 1 BOX 06/09/2020 2 0.8 g in 1 PACKAGE; Type 0: Not a Combination Product 3 NDC:78804-215-00 300 in 1 BOX 06/09/2020 3 0.8 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/09/2020 Labeler - Allure Chemicals LP (080442496) Establishment Name Address ID/FEI Business Operations Allure Chemicals LP 080442496 manufacture(78804-215)