Defender By GSD Sanitzing Wipes

Defender By GSD Sanitzing Wipes by

Drug Labeling and Warnings

Defender By GSD Sanitzing Wipes by is a Otc medication manufactured, distributed, or labeled by Joco Sales and Marketing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DEFENDER BY GSD SANITZING WIPES- benzalkonium chloride cloth 
Joco Sales and 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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Defender By GSD Sanitzing Wipes

Drug Facts

Active ingredients

Benzalknium 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 meidcal help, or contact a Poison Control Center immediately.

Directions 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), Glycerol, Propanediol, Lemon extract, HexadecylPyridinium chloride, Chlorphenesin, Vitamin E, Citric acid, Sodium citrate.

Package Labeling: 160 wipes

Box

Package Labeling: 800 wipes

Box2

Package Labeling: 65 wipes

65 wipes

DEFENDER BY GSD SANITZING WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77784-003
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
LEMON (UNII: 24RS0A988O)  
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77784-003-01160 in 1 CANISTER11/03/202007/01/2022
14.17 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC: 77784-003-02800 in 1 PAIL11/03/202007/01/2022
23.66 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC: 77784-003-0365 in 1 CANISTER11/04/202007/01/2022
34.17 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 finalpart333E11/03/202007/01/2022
Labeler - Joco Sales and Marketing, Inc. (157016291)

Revised: 10/2022
Document Id: eb751c11-411c-f5a6-e053-2a95a90abdcb
Set id: b3347c67-27fe-47bd-e053-2a95a90a3077
Version: 3
Effective Time: 20221020