HAND SANITIZER by ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD HAND SANITIZER gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGERDIENT

Ethyl Alcohol 70%.

PURPOSE

Antiseptic

USES

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

For external use only.
Flammable. Keep away from heat or flame. Keep out of reach of children.
If swallowed, get medical help or contact
Poison Control Center right away.

DO NOT USE

on open skin wounds.
on children under the age of 2 months.

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

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
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 59°-86°F(15°-30°C)
Avoid treezing and excessive heat above 104°F(40 °C)

INACTIVE INGERDIENTS

Purified Water,Glycerin,Triethanolamine,Carbomer,Vitamin E.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74763-003
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
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74763-003-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020
2	NDC: 74763-003-02	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020
3	NDC: 74763-003-03	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/30/2020

Labeler - ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD (550707836)

Registrant - ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD (550707836)

Establishment
Name	Address	ID/FEI	Business Operations
ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD		550707836	manufacture(74763-003)