INSTANT HAND SANITIZER gel

INSTANT HAND SANITIZER by

Drug Labeling and Warnings

INSTANT HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Yangzhou Aplus Amenities International Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient[s]

Alcohol 75%

Purpose

Antiseptic

Use[s]

Hand Sanitizer to decrease bacteria on the skin that could cause disease.

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 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.

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

Carbomer,Glycerin,Aloe Extract,Triethanolamine,Water.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
instant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77970-001
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
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE (UNII: V5VD430YW9)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77970-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020
2	NDC: 77970-001-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/18/2020

Labeler - Yangzhou Aplus Amenities International Co., Ltd. (554532431)

Registrant - Yangzhou Aplus Amenities International Co., Ltd. (554532431)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Aplus Amenities International Co., Ltd.		554532431	manufacture(77970-001)