GSD Defender Good Hygiene Defense Wet Wipes

GSD Defender Good Hygiene Defense Wet Wipes by

Drug Labeling and Warnings

GSD Defender Good Hygiene Defense Wet Wipes by is a Otc medication manufactured, distributed, or labeled by JoCo Sales & Marketing, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GSD DEFENDER GOOD HYGIENE DEFENSE WET WIPES- benzalkonium chloride cloth 
JoCo Sales & Marketing, Inc

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.

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GSD Defender Good Hygiene Defense Wet Wipes

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

For hand washing to decrease bacteria on the skin. Recommended for repeat use.

Warnings

  • For external use only.
  • Keep out of reach of eyes. If contact occurs, rinse thoroughly with water.

Do not use

  • if you are allergic to any of the ingredients.
  • Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.

Keep out of reach of children

  • unless under adult supervision.
  • If swallowed, get medical help, or contact a Poison Control Center immediately.

Direction of use

  • Open resealable label and pull one sheet from pack. Thoroughly clean hands or affected area and discard in receptacle, and do not flush. Allow to dry without wiping. Be sure to reseal label complete to retain moisture.

Other Information

  • Store at room temperature.

Inactive Ingredients

Water (Aqua), Lemon extract, Dipentene, Ethylhexylglycerin, Propylene Glycol, Cetylpyridinium Chloride, 2-Phenoxyethanol.

Package Labeling:

Label

GSD DEFENDER GOOD HYGIENE DEFENSE WET WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77784-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LEMON (UNII: 24RS0A988O)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77784-002-8080 in 1 BAG07/15/202007/01/2022
15.4 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/15/202007/01/2022
Labeler - JoCo Sales & Marketing, Inc (157016291)

Revised: 10/2022
Document Id: eb75073a-25ce-7d56-e053-2a95a90ab380
Set id: 667c9be1-160e-4819-ac92-0dfe3bef1e65
Version: 3
Effective Time: 20221020