PURE SKIN FAMILY HANDTIZER- alcohol gel

PURE SKIN Family Handtizer by

Drug Labeling and Warnings

PURE SKIN Family Handtizer by is a Otc medication manufactured, distributed, or labeled by COSTEM CO.,LTD, ICOMAX Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Ethyl Alcohol 70.0%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Glycerin, Butylene Glycol, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate, Carbomer, Triethanolamine, CI 19140(Yellow5), CI 42090(Blue1), 1,2-Hexanediol, Caprylyl Glycol, Fragrance, Alpha-Isomethyl Ionone, Citronellol, Hexyl Cinnamal, Linalool, Butylphenyl Methylpropional

PURPOSE

Purpose: Antibacterial

WARNINGS

Warnings:

For external use only.
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Flammable.
Keep away from heat or flame
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When using this product
Do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water
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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

Uses

Uses:

Hand sanitizer to help reduce bacteria on the skin

Directions

Directions:

Pump into palms and thoroughly rub into skin until dry

Package Label - PURE SKIN Family Handtizer 80mL

Package Label - PURE SKIN Family Handtizer 300mL

INGREDIENTS AND APPEARANCE

PURE SKIN FAMILY HANDTIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75370-010
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)
Glycerin (UNII: PDC6A3C0OX)
Butylene Glycol (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
1,2-Hexanediol (UNII: TR046Y3K1G)
Caprylyl Glycol (UNII: 00YIU5438U)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
Butylphenyl Methylpropional (UNII: T7540GJV69)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75370-010-01	80 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2020
2	NDC: 75370-010-02	300 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 - COSTEM CO.,LTD (695673235)

Registrant - COSTEM CO.,LTD (695673235)

Establishment
Name	Address	ID/FEI	Business Operations
ICOMAX Co., Ltd.		694834031	manufacture(75370-010)