ISNER MILE HAND SANITIZER- alcohol gel

ISNER MILE Hand Sanitizer by

Drug Labeling and Warnings

ISNER MILE Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Water 24.2%, Alcohol Carbomer 0.4%, Triethanolamine 0.4%, Glycerin 2%, Propylene Glycol 0.5%

,Aloe Barbadensis Leaf Juice 2%, Tocopheryl Acetate 0.5%

Active Ingredient(s)

Ethyl Alcohol 70.0%
Purpose: Antimicrobial

Purpose

Antiseptic, Hand Sanitizer

Use

To 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, rinse eyes thoroughly with water.
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.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

480 mL NDC: 78098-004-01 118 mL NDC: 78098-004-02 250 mL NDC: 78098-004-04 60 mL NDC: 78098-004-03

INGREDIENTS AND APPEARANCE

ISNER MILE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78098-004
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
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	2 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)	0.4 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)	0.4 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	2 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78098-004-01	480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
2	NDC: 78098-004-02	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 78098-004-03	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
4	NDC: 78098-004-04	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD (554457375)

Registrant - GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD (554457375)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD		554457375	manufacture(78098-004)