FIRST HANDS PREMIUM HAND SANITIZER- alcohol gel

First Hands premium hand sanitizer by

Drug Labeling and Warnings

First Hands premium hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Samhyun pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Ethanol 70% w/w

INACTIVE INGREDIENT

Inactive ingredients:

Water, Triethanolamine, Carbomer, Glycerin, Propylene glycol, Herb aroma, Poly-gamma glutamic acid

PURPOSE

Purpose: ANTISEPTIC

WARNINGS

Warnings:

For external use only. Flammable. Keep away from heat or flame
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Do not use
in children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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

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

Uses

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

Directions:

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

Other information

Other information
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Package Label : First Hands premium hand sanitizer gel 100mL

Package Label : First Hands premium hand sanitizer gel 500mL

INGREDIENTS AND APPEARANCE

FIRST HANDS PREMIUM HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75765-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Glycerin (UNII: PDC6A3C0OX)
Propylene glycol (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75765-020-01	100 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/01/2020
2	NDC: 75765-020-02	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2020

Labeler - Samhyun pharma (694185214)

Registrant - Samhyun pharma (694185214)

Establishment
Name	Address	ID/FEI	Business Operations
Samhyun pharma		694185214	manufacture(75765-020)