Personal Protection Pack Kit

Personal Protection Pack by

Drug Labeling and Warnings

Personal Protection Pack by is a Otc medication manufactured, distributed, or labeled by Global-C Nederland B.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PERSONAL PROTECTION PACK- alcohol 
Global-C Nederland B.V.

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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Personal Protection Pack Kit

Drug Facts

Active ingredient

Ethyl alcohol 65%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use only. Flammable, keep away from fire or flame.

Do not use

in the eyes.

Stop use and ask a doctor if 

• irritation and redness develops
• 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

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store below 77 °F (25 °C)

Inactive ingredients

alpha tocopheryl acetate, monopropylene glycol, peg-7 glyceryl cocoate, polyacrylic acid, triclosan, triethanolamine, water

Drug Facts

Active ingredient

Ethyl alcohol 65%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

or external use only

Flammable, keep away from fire or flame.

Do not use

in the eyes.

Stop use and ask a doctor if

• irritation and redness develops
• 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

wet hands thoroughly with product and allow to dry without wiping.

Other information

Store below 77 °F (25 °C)

Inactive ingredients

cellulose fiber, PEG -7 glyceryl cocoate, polyester fiber, water

Drug Facts

Active ingredient

Ethyl alcohol 65%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use

in the eyes.

Stop use and ask a doctor if

• irritation and redness develops
• 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

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store below 77 °F (25 °C)

Inactive ingredients

alpha tocopheryl acetate, monopropylene glycol, peg-7 glyceryl cocoate, polyacrylic acid, triclosan, triethanolamine, water

Package Labeling: Kit

Package Labeling: 1 Towel

Package Labeling: 3ML

PERSONAL PROTECTION PACK 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78657-000

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78657-000-01	1 in 1 KIT	06/30/2020	06/30/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 PATCH	6 mL
Part 2	1 BAG	3 mL

Part 1 of 2

ANTISEPTIC TOWEL 65 ETHYL ALCOHOL 
alcohol cloth

Product Information
Item Code (Source)	NDC: 78657-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.65 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78657-001-01	2 in 1 POUCH
1		3 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	06/30/2020

Part 2 of 2

ALCOHOL 
antiseptic hand sanitizer 65 ethyl gel

Product Information
Item Code (Source)	NDC: 78657-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.65 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRICLOSAN (UNII: 4NM5039Y5X)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78657-002-01	3 mL in 1 BAG; 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	part333E	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/30/2020	06/30/2020

Labeler - Global-C Nederland B.V. (386762558)

Revised: 8/2020

Document Id: ad28158d-3982-e72a-e053-2995a90ae588

34390-5

Set id: a9616b4c-8b2f-3ed9-e053-2a95a90a1885

Version: 2

Effective Time: 20200818