Label: ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 78870-901-01, 78870-901-02 - Packager: AMERICAN EXCHANGE TIME 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 June 22, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- USE
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Warning
For external use only. Do not use:
●In children less than 2 months of age.
●On open skin wounds.
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 iritation or rash occurs. These may be signs of a serious
condition. - Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND WIPES
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78870-901 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 g Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) POLYSORBATE 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78870-901-01 80 in 1 BAG 06/23/2020 1 420 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:78870-901-02 15 in 1 BAG 06/23/2020 2 82 g in 1 POUCH; 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 06/22/2020 Labeler - AMERICAN EXCHANGE TIME LLC (830332164) Establishment Name Address ID/FEI Business Operations Kangna (Zhejiang) Medical Supplies Co., Ltd. 554530173 manufacture(78870-901)