Label: I.C. ANTIBACTERIAL HAND CLEANER WITH PUMICE- benzalkonium chloride soap
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NDC Code(s):
59555-501-04,
59555-501-08,
59555-501-09,
59555-501-10, view more59555-501-11
- Packager: R & R Lotion, Inc
- Category: HUMAN OTC DRUG LABEL
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 October 7, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Inactive Ingredients
- Samples & Comments?
- PRINCIPAL DISPLAY PANEL - 946 ml Bottle Label
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INGREDIENTS AND APPEARANCE
I.C. ANTIBACTERIAL HAND CLEANER WITH PUMICE
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Triethanolamine Lauryl Sulfate (UNII: E8458C1KAA) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) COCO MONOETHANOLAMIDE (UNII: C80684146D) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLUCONOLACTONE (UNII: WQ29KQ9POT) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3) TROLAMINE (UNII: 9O3K93S3TK) Xanthan Gum (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-501-04 59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/01/2021 2 NDC:59555-501-08 236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 07/01/2021 3 NDC:59555-501-09 473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 07/01/2021 4 NDC:59555-501-10 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/01/2021 5 NDC:59555-501-11 3780 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 07/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 07/01/2021 Labeler - R & R Lotion, Inc (062979000)