Label: QUATRO SHIELD HAND SANITIZER- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78873-609-10, 78873-609-25, 78873-609-50 - Packager: QUATRO SHIELD 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 26, 2020
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
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Package Label - Principal Display Panel
TELEPHONE: 1-888-QUATRO-5
MONDAY THROUGH FRIDAY 8:00 AM UNTIL 5:00 PM EST
WATER BASED FORMULA
QUATRO SHIELD
LONG-LASTING PROTECTION
ALCOHOL-FREE
HAND SANITIZER
KILLS 99.9% OF GERMS
Kills more than 99.99% of many common harmful germs and bacteria that may cause ilnness.
Distributed by:
Quatro Shield LLC
67 Plaza Fabiana
Vega Alta, PR 00692
www.Quatroshield.com
Product of Turkey
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INGREDIENTS AND APPEARANCE
QUATRO SHIELD HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78873-609 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78873-609-25 250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/30/2020 2 NDC:78873-609-50 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/30/2020 3 NDC:78873-609-10 1000 mL in 1 BOTTLE, PUMP; 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 - QUATRO SHIELD LLC (117550310) Registrant - HARDAL GLOBAL CONSULTING LLC. (123584960) Establishment Name Address ID/FEI Business Operations QUATRO SHIELD LLC 117550310 label(78873-609) Establishment Name Address ID/FEI Business Operations QUATRO KIMYA SANAYI TICARET LIMITED SIRKETI 595805184 manufacture(78873-609)