GERMY GONE HAND SANITIZER- alcohol gel 
GERMY GONE 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

Alcohol 70% v/v. 

Purpose

Antiseptic

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.

Directions

Other information

Inactive ingredients

glycerin, isopropyl myristate, methacrylic acid, propylene glycol, purified water USP, tetrahydroxypropyl ethylenediamine, vitamin E

Product Label

image description

GERMY GONE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79725-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
CUMINYL ACETALDEHYDE (UNII: WSW8QXE6HG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79725-001-0118 mL in 1 PACKAGE; Type 0: Not a Combination Product07/10/2020
2NDC:79725-001-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
3NDC:79725-001-03118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
4NDC:79725-001-04237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
5NDC:79725-001-05355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
6NDC:79725-001-06473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
7NDC:79725-001-07500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
8NDC:79725-001-08946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
9NDC:79725-001-091000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
10NDC:79725-001-103785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
11NDC:79725-001-114000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/10/2020
Labeler - GERMY GONE LLC (117581441)

Revised: 7/2020
Document Id: a78b63ee-f8ba-4fff-9244-8cd698e2c97a
Set id: 99e8567f-1bdf-487c-921a-2f926aad5215
Version: 1
Effective Time: 20200709
 
GERMY GONE LLC