VOP.1 SAFETY SANITIZER- alcohol gel

VOP.1 Safety Sanitizer by

Drug Labeling and Warnings

VOP.1 Safety Sanitizer by is a Otc medication manufactured, distributed, or labeled by Crown United, Samhyun pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ALCOHOL 70% w/w

INACTIVE INGREDIENTS

Water, Herb aroma HF-31002, Triethanolamine, Glycerin, Propylene glycol, Carbomer, Polygamma glutamic acid

Purpose

ANTISEPTIC

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

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

instant hand antiseptic to decrease bacteria on the skin
recommended for repeated use

Directions

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.
Supervise children in the use of this product.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
May discolor some fabrics
Harmful to wood finishes and plastics

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VOP.1 SAFETY SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77815-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 g  in 500 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77815-010-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020

Labeler - Crown United (694803095)

Registrant - Crown United (694803095)

Establishment
Name	Address	ID/FEI	Business Operations
Samhyun pharma		694185214	manufacture(77815-010)