LUOYS HAND SANITIER- alcohol gel

LUOYS Hand Sanitier by

Drug Labeling and Warnings

LUOYS Hand Sanitier by is a Otc medication manufactured, distributed, or labeled by ZheJiang Yiwu Limei Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NA

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For hand sanitizing to help decrease bacteria on the skin

Recommended for repeated use

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

STOP USE

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours

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

• Pump a small amount into palm of hands
• Rub thoroughly over all surface of both hands
• Rub hands together briskly untill dry

Other information

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

Inactive ingredients

Water, propylene glycol, glycerin, carbomer, triethanolamine

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

LUOYS HAND SANITIER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74765-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74765-001-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
2	NDC: 74765-001-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
3	NDC: 74765-001-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
4	NDC: 74765-001-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
5	NDC: 74765-001-05	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
6	NDC: 74765-001-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
7	NDC: 74765-001-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
8	NDC: 74765-001-08	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
9	NDC: 74765-001-09	3000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
10	NDC: 74765-001-10	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/08/2020

Labeler - ZheJiang Yiwu Limei Cosmetics Co., Ltd (679892245)

Establishment
Name	Address	ID/FEI	Business Operations
ZheJiang Yiwu Limei Cosmetics Co., Ltd		679892245	manufacture(74765-001)