STE-MEDI by ELLAMUSE KOREA STE-MEDI- alcohol gel

STE-MEDI by

Drug Labeling and Warnings

STE-MEDI by is a Otc medication manufactured, distributed, or labeled by ELLAMUSE KOREA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

Hand Sanitizer to reduce bacteria on the skin

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, nise thoroughly with water. Do not inhale or ingest.

Stop use and ask a doctor if

Irritation or redness develops. Condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact 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 105F. May discolor certain fabrics.

Inactive ingredients

Water, Sodium Hyaluronate, Chitosan, Allantoin, Hamamelis Virginiana (Witch Hazel) Extract, Carbomer

Package Label

INGREDIENTS AND APPEARANCE

STE-MEDI 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77599-201
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
ALLANTOIN (UNII: 344S277G0Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
POLIGLUSAM HYDROCHLORIDE (UNII: F351U03I47)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77599-201-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2020
2	NDC: 77599-201-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2020
3	NDC: 77599-201-03	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/13/2020
4	NDC: 77599-201-04	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/13/2020
5	NDC: 77599-201-05	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/13/2020

Labeler - ELLAMUSE KOREA (695538826)

Registrant - ELLAMUSE KOREA (695538826)

Establishment
Name	Address	ID/FEI	Business Operations
ELLAMUSE KOREA		695538826	manufacture(77599-201)