SAFE HAND CLEAN GEL- alcohol gel

SAFE HAND CLEAN gel by

Drug Labeling and Warnings

SAFE HAND CLEAN gel by is a Otc medication manufactured, distributed, or labeled by ACE PHARMACEUTICAL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ethanol

INACTIVE INGREDIENT

Glycerin
Butylene Glycol
Sodium Hyaluronate
Carbomer
Triethanolamine
Fragrance
Camellia Sinensis Leaf Extract
Aloe Barbadensis Leaf Juice
Water

PURPOSE

hand sanitizer to help reduce bacteria that potentially can cause disease

for use when soap and water are not available

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry

WARNINGS

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SAFE HAND CLEAN GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74196-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74196-0002-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2020
2	NDC: 74196-0002-2	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2020
3	NDC: 74196-0002-3	60 mL in 1 TUBE; Type 0: Not a Combination Product	04/02/2020
4	NDC: 74196-0002-4	3 mL in 1 POUCH; Type 0: Not a Combination Product	04/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/02/2020

Labeler - ACE PHARMACEUTICAL CO LTD (689058677)

Registrant - ACE PHARMACEUTICAL CO LTD (689058677)

Establishment
Name	Address	ID/FEI	Business Operations
ACE PHARMACEUTICAL CO LTD		689058677	manufacture(74196-0002)