FIRST HANDS PREMIUM HAND SANITIZER- alcohol gel 
Samhyun pharma

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

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

Image of container

Package Label : First Hands premium hand sanitizer gel 500mL

Image of bottle

FIRST HANDS PREMIUM HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75765-020
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75765-020-01100 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
2NDC:75765-020-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2020
Labeler - Samhyun pharma (694185214)
Registrant - Samhyun pharma (694185214)
Establishment
NameAddressID/FEIBusiness Operations
Samhyun pharma694185214manufacture(75765-020)

Revised: 4/2020
Document Id: 5d1fdd6b-3ea8-4171-8f19-b4283657b939
Set id: b2f88daa-85e6-424c-abbd-dbbb95a7adb7
Version: 1
Effective Time: 20200428
 
Samhyun pharma