Label: DISINFECTING WIPES- benzalkonium chloride,didecyl dimethyl ammonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 75328-301-01, 75328-301-02, 75328-301-03, 75328-301-04, view more75328-301-05, 75328-301-06, 75328-301-07, 75328-301-08, 75328-301-09, 75328-301-10 - Packager: CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.
- 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 July 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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
DISINFECTING WIPES
benzalkonium chloride,didecyl dimethyl ammonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75328-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE 0.2 in 100 BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.2 in 100 Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75328-301-01 1 in 1 BAG; Type 0: Not a Combination Product 03/30/2020 2 NDC:75328-301-02 10 in 1 BAG; Type 0: Not a Combination Product 03/30/2020 3 NDC:75328-301-03 20 in 1 BAG; Type 0: Not a Combination Product 03/30/2020 4 NDC:75328-301-04 30 in 1 BAG; Type 0: Not a Combination Product 03/30/2020 5 NDC:75328-301-05 50 in 1 BAG; Type 0: Not a Combination Product 03/30/2020 6 NDC:75328-301-06 75 in 1 BAG; Type 0: Not a Combination Product 03/30/2020 7 NDC:75328-301-07 80 in 1 BAG; Type 0: Not a Combination Product 03/30/2020 8 NDC:75328-301-08 100 in 1 BAG; Type 0: Not a Combination Product 03/30/2020 9 NDC:75328-301-09 120 in 1 BAG; Type 0: Not a Combination Product 03/30/2020 10 NDC:75328-301-10 160 in 1 BAG; 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 - CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. (542978427) Establishment Name Address ID/FEI Business Operations CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. 542978427 manufacture(75328-301)
