INSTANT HAND SANITIZER- hand sanitizer kit

INSTANT HAND SANITIZER by

Drug Labeling and Warnings

INSTANT HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by NINGBO CLEANER DAILY USED PRODUCTS CO. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Ethyl Alcohol  62%

Purpose

Antiseptic

Warnings

For external use only

• flammable, keep away from fire and flame
• will produce serious gastric disturbances if taken internally
  

Ask a doctor before use if you have deep puncture wounds or serious burns

When using this product

• do not get into eyes or mucous membranes
• use only in a well-ventilated area

Stop use and ask a doctor if condition persists or gets worse.

Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

Uses

hand sanitizer to help decrease bacteria on the skin. when water, soap and towel are not available. recommended for repeated use

Warnings

• For external use only
• Flammable
• Keep away from fire or flame
  

Do not apply around eyes. Do not use in ears and mouth.

When using this product, avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children. Children must be supervised in use of this product.

Directions

pump as needed into your palms and thoroughly spread on both hands. rub skin until dry.

Other information

store at 20 degree celsius (68 degrees to 77 degrees fahrenheit). may discolor fabrics.

Inactive ingredients

water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, aloe barbadensis gel, carbomer, fragrance

Package Label

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
hand sanitizer kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 18018-501

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 18018-501-34	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	1000 mL
Part 2	1 BOTTLE, PUMP	237 mL

Part 1 of 2

INSTANT HAND SANITIZER 
hand sanitizer gel

Product Information
Item Code (Source)	NDC: 18018-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1000 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	11/01/2009

Part 2 of 2

INSTANT HAND SANITIZER 
hand sanitizer gel

Product Information
Item Code (Source)	NDC: 18018-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		237 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	11/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	11/01/2009

Labeler - NINGBO CLEANER DAILY USED PRODUCTS CO. LTD. (527983808)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO CLEANER DAILY USED PRODUCTS CO. LTD.		527983808	manufacture