HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Newacme LLC, SHANDISHI Biological Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses:

For Hand Sanitizing.

Warnings:

For external use only-hands.

Flammable: Keep away from heat and flame.

When using this product

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• Avoid contact with broken skin.
• Do not inhale or ingest.

Stop use and ask a doctor

If skin irritation develops.

Keep out of reach of children.

If swallowed, get medical help or call a Poison Control Center right away.

Directions:

Wet hands thoroughly with product and allow to dry without wiping

• For children under 6 use only under adult Supervision.
• Not recommended for infants.

Other information:

Do not store above 105°F.

• May discolor some fabrics.
• Harmful to wood finishes and plastics.

Inactive ingredients:

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Package Labeling:1000ml

Package Labeling:2000ml

Package Labeling:3.780ml

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74341-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74341-004-12	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
2	NDC: 74341-004-13	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
3	NDC: 74341-004-14	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/20/2020

Labeler - Newacme LLC (117465743)

Establishment
Name	Address	ID/FEI	Business Operations
SHANDISHI Biological Technology Co., Ltd.		411868994	manufacture(74341-004)