GSD Santizing Wipes by Joco Sales and Marketing, Inc. GSD Santizing Wipes

GSD Santizing Wipes by

Drug Labeling and Warnings

GSD Santizing 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]

GSD SANTIZING 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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GSD Santizing Wipes

Drug Facts

Active ingredients

Benzalkonium Chloride 0.10%

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), Glycerol, Propanediol, Aloe Vera Extract, Amino acid moisturizer, Hexadecylpyridinium Chloride, Chlorphenesin, Vitamin E, Citric acid, Sodium citrate.

Package Labeling:

GSD SANTIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77784-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BETAINE (UNII: 3SCV180C9W)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77784-004-65	65 in 1 CANISTER	11/04/2020	07/01/2022
1		4.17 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/04/2020	07/01/2022

Labeler - Joco Sales and Marketing, Inc. (157016291)

Revised: 10/2022

Document Id: eb752ef8-67c5-7e77-e053-2a95a90a5b5f

34390-5

Set id: b34992d1-a9d1-2574-e053-2a95a90ab5c4

Version: 2

Effective Time: 20221020