HYGIENEX LINEN BREEZE HAND SANITIZER- alcohol gel 
Global Impact Innovation LLC

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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Active Ingredient(s)

Alcohol 72% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

glycerin, water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, AMP, Tocopherol Acetate, Fragrance(s)

Package Label - Principal Display Panel

HGXLBGel1GLabel

1 Gallon NDC: 74588-795-04

HGXLBGel5GLabel

5 Gallon NDC: 74588-795-05

HGXLBGel55GLabel

55 Gallon NDC: 74588-795-01

HGXLBGel275GLabel

275 Gallon NDC: 74588-795-02

HGXLBGel330GLabel

330 Gallon NDC: 74588-795-03

HGXLBGel16ozLabel

16 Oz NDC: 74588-795-11

HGXLBGel32ozLabel

32 Oz NDC: 74588-795-12

HGXLBGel64ozLabel

64 Oz NDC: 74588-795-13

HYGIENEX LINEN BREEZE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74588-795
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74588-795-043785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:74588-795-12946.353 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:74588-795-11473.176 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:74588-795-0518927 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
5NDC:74588-795-01208198 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
6NDC:74588-795-021040990 mL in 1 TANK; Type 0: Not a Combination Product03/30/2020
7NDC:74588-795-031249190 mL in 1 TANK; Type 0: Not a Combination Product03/30/2020
8NDC:74588-795-131890 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Global Impact Innovation LLC (117465830)

Revised: 8/2020
Document Id: ac9f9787-e019-fc89-e053-2995a90a5c25
Set id: aa82bf88-d847-46dc-e053-2a95a90ad5fc
Version: 2
Effective Time: 20200811
 
Global Impact Innovation LLC