Hand Sanitizer Gel by AgroChem Inc Hand Sanitzer Gel

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by AgroChem Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER GEL- alcohol liquid solution 
AgroChem 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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Hand Sanitzer Gel

Hand Sanitizer Gel

Moisturizing with Aloe

Effective at eliminating more then 99.9% of many common harmful germs & bacteria in as little as 15 seconds.

Active ingredient

Isopropyl Alcohol 75% v/v

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Recommended for repeated use

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry.

No rinsing required.  No towels needed.

Inactive ingredients

Water (Aqua), Aloe Vera, Propylene Glycol, Carbomer

HAND SANITIZER GEL 
alcohol liquid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17307-1100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.75 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17307-1100-1	0.45 kg in 1 CONTAINER; Type 0: Not a Combination Product	03/23/2020
2	NDC: 17307-1100-2	0.9 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/23/2020
3	NDC: 17307-1100-3	3.62 kg in 1 KIT; Type 0: Not a Combination Product	03/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/23/2020	04/04/2020

Labeler - AgroChem Inc (805427700)

Registrant - AgroChem Inc (805427700)

Establishment
Name	Address	ID/FEI	Business Operations
AgroChem Inc		805427700	manufacture(17307-1100)

Revised: 4/2020

Document Id: a279227d-fc96-5955-e053-2995a90a322f

34390-5

Set id: 5d372736-5707-4e3c-8483-5a89baeeb329

Version: 3

Effective Time: 20200404

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