STERELLE HAND SANITIZER- alcohol gel

STERELLE Hand Sanitizer by

Drug Labeling and Warnings

STERELLE Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by URBANBCL CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ethyl alcohol

PURPOSE

to decrease bacteria on the skin that could cause disease

recommended for repeated use

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

WARNINGS

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

DOSAGE & ADMINISTRATION

for external use only

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Trolamine
Glycerin
Dipropylene Glycol
Water

INDICATIONS & USAGE

wet hands thoroughly with product and allow to dry without wiping

for children under 6, use only under adult supervision

not recommended for infants

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STERELLE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74200-0027
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
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74200-0027-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/27/2020

Labeler - URBANBCL CO LTD (694794065)

Registrant - URBANBCL CO LTD (694794065)

Establishment
Name	Address	ID/FEI	Business Operations
URBANBCL CO LTD		694794065	manufacture(74200-0027)