PURE CLEAN PREMIUM HAND SANITIZER- hand sanitizer gel

Pure Clean Premium Hand Sanitizer by

Drug Labeling and Warnings

Pure Clean Premium Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by WOMANSWORLD Co., Ltd., ICOMAX Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 75% v/v

Purpose

Antiseptic

Use

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

Warnings

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

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of 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.

Directions

• Place enough product on your palm to thoroughly cover your hands.
• Rub hands together briskly until dry.
• Supervise children when using this product to avoid swallowing.

Other Information

• Store between 15-30 °C (59-86°F).
• Avoid freezing and excessive heat above 104°F(40°C).
• May discolor certain fabrics or surface.

Inactive Ingredients

Water, Butylene Glycol, Glycerin, Aloe Vera Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

PURE CLEAN PREMIUM HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77708-002
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
TROLAMINE (UNII: 9O3K93S3TK)	0.2 mL  in 100 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)	0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	21.28988 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	2 mL  in 100 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH)	0.0001 mL  in 100 mL
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	0.00022 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.0098 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77708-002-40	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/19/2020

Labeler - WOMANSWORLD Co., Ltd. (688320057)

Registrant - WOMANSWORLD Co., Ltd. (688320057)

Establishment
Name	Address	ID/FEI	Business Operations
ICOMAX Co., Ltd.		694834031	manufacture(77708-002)