STE-MEDI- hypochlorous acid liquid

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

Hypochlorous acid water (HOCL) 90%

Ethyl Alcohol 5%

Tea tree oil 0.2%, Chamaecyparis obtusa oil 0.15%, Lavender oil 0.15%

Purpose

Antiseptic

Uses

Hand Sanitizer to reduce skin bacteria and viruses on the skin

Warnings

External use only: hand

When disinfecting the object, spray it and wipe it with a dry cotton cloth.

When using this product

Avoid the eyes. If it gets into your eyes, rinse them thoroughly with water.

Do not inhale or ingest.

Stop use and ask a doctor if

Irritation or redness develops

Keep out of reach of children.

If swallowed, seek medical attention.

Directions

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only adult supervision

Not recommended for infants

Other information

Do not store above 105F

May discolor certain fabrics

Inactive ingredients

Hyaluronic acid, chitosan, allantoin, witch hazel extract

Package Label

INGREDIENTS AND APPEARANCE

STE-MEDI 
hypochlorous acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77599-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	90 g  in 100 mL
TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G)	TEA TREE OIL	0.2 g  in 100 mL
CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62) (CHAMAECYPARIS OBTUSA WOOD OIL - UNII:P2OMP71Y62)	CHAMAECYPARIS OBTUSA WOOD OIL	0.15 g  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8) (LAVENDER OIL - UNII:ZBP1YXW0H8)	LAVENDER OIL	0.15 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYALURONIC ACID (UNII: S270N0TRQY)
POLIGLUSAM HYDROCHLORIDE (UNII: F351U03I47)
ALLANTOIN (UNII: 344S277G0Z)
WITCH HAZEL (UNII: 101I4J0U34)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77599-202-01	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/04/2020
2	NDC: 77599-202-02	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/04/2020
3	NDC: 77599-202-03	200 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/04/2020
4	NDC: 77599-202-04	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/04/2020
5	NDC: 77599-202-05	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/04/2020

Labeler - ELLAMUSE KOREA (695538826)

Registrant - ELLAMUSE KOREA (695538826)

Establishment
Name	Address	ID/FEI	Business Operations
ELLAMUSE KOREA		695538826	manufacture(77599-202)