AGACHY FAST CLEAN HAND SANITIZER- hand sanitizer gel

AGACHY FAST CLEAN HAND SANITIZER by

Drug Labeling and Warnings

AGACHY FAST CLEAN HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by ICOMAX Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

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

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Place enough product on your palm to cover all surfaces and rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Avoid freezing and excessive heat above 40C (104F)
• May discolor certain fabrics or surface

Inactive ingredients

Water, Butylene Glycol, Glycerin, Carbomer, Triethanolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Package Label - Principal Display Panel

500 mL NDC: 77201-001-50

INGREDIENTS AND APPEARANCE

AGACHY FAST CLEAN HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77201-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)	0.01 mL  in 100 mL
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	0.0005 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	21.4195 mL  in 100 mL
LEVOMENTHOL (UNII: BZ1R15MTK7)	0.02 mL  in 100 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)	0.4 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.14 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.01 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77201-001-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/18/2020

Labeler - ICOMAX Co., Ltd. (694834031)

Establishment
Name	Address	ID/FEI	Business Operations
ICOMAX Co., Ltd.		694834031	manufacture(77201-001)