Label: BENZOCLEAN HAND SANITIZER- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 53113-090-08 - Packager: GADAL Laboratories, Inc
- 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 11, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
ADVANCED
MOISTURIZING
LONG-LASTING GEL
WITH ALOE VERA & VITAMIN E
KILLS 99.9% OF GERMS
*Kills Most Viruses
*Moisturizes & Leaves
Hands Feeling Smooth
MADE IN THE USA
GMP GOOD MANUFACTURING PRACTICE QUALITY PRODUCT
Distributed by: PCO Foods • 1110 Powers Place Alpharetta, GA, 30009 • pcofoods.com Questions or comments: sales@pcofoods.com
- Packaging
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INGREDIENTS AND APPEARANCE
BENZOCLEAN HAND SANITIZER
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53113-090 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 WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) DMDM HYDANTOIN (UNII: BYR0546TOW) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53113-090-08 236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/01/2020 Labeler - GADAL Laboratories, Inc (841305639) Establishment Name Address ID/FEI Business Operations GADAL Laboratories, Inc 841305639 manufacture(53113-090)