Label: PROTECT U GUARD ANTIBACTERIAL FOAMING- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 71788-001-10, 71788-001-20, 71788-001-50, 71788-001-60 - Packager: Protect U Guard, 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 4, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only.
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
Stop Use and Ask a Doctor of irritation or redness develops, or if condition persists for more than 72 hours.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROTECT U GUARD ANTIBACTERIAL FOAMING
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71788-001 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 LAURAMINE OXIDE (UNII: 4F6FC4MI8W) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71788-001-60 12 in 1 CARTON 06/03/2020 1 NDC:71788-001-50 530 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:71788-001-20 4 in 1 CARTON 06/03/2020 2 NDC:71788-001-10 1000 mL in 1 BOTTLE, DISPENSING; 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 06/03/2020 Labeler - Protect U Guard, LLC (080070945) Establishment Name Address ID/FEI Business Operations Protect U Guard, LLC 080070945 relabel(71788-001) Establishment Name Address ID/FEI Business Operations Whisk Products Inc 834270639 manufacture(71788-001)
