ZERO HAND SANITIZER- rosemary, chamomile, melaleuca alternifolia leaf, lavandula angustifolia liquid

ZERO Hand Sanitizer by

Drug Labeling and Warnings

ZERO Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by FORMULA, Daraeworld Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:
Rosmarinus Officinalis (Rosemary) Leaf Extract 1%
Chamomilla Recutita (Matricaria) Flower Extract1%
Melaleuca Alternifolia (Tea Tree) Leaf Extract 1%
Lavandula Angustifolia (Lavender) Flower Extract 1%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Scutellaria Baicalensis Root Extract, Rhus Semialata Extract, Terminalia Chebula Fruit Extract, Morus Alba Bark Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Butylene Glycol, Boswellia Serrata Extract, Centella Asiatica Extract, Camellia Sinensis Leaf Extract, Actinidia Arguta Fruit Extract, Citrus Paradisi (Grapefruit) Seed Extract, Chamaecyparis Obtusa Water, Flavor

PURPOSE

Purpose: SANITIZER

WARNINGS

Warnings:

1.Do not use the product on the following areas:
Eyes, mouth, and damaged skin (irritation may occur)
2.If you experience any of the following symptoms, stop using the product immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms (e.g. rash, erythema, itching and edema)
2) Skin irritation symptoms
3. Other precautions
1) For external use only. (Do not swallow. If swallowed, vomit and consult a doctor or pharmacist)
2) Avoid contact with eyes. If in contact, wash with clean water and consult a doctor or pharmacist.
3) Do not use sealed bandages, cast bandages or packs as they may cause irritation.
4) Do not use this medicine for anal or vaginal areas or hot packs as it may cause irritation.
5) Use only for the intended purpose.
4.Precautions for storage
1) Keep away from direct sunlight and do not expose the product to heating devices or flame.
2) Keep out of reach of children and go to the hospital immediately if swallowed.
3) After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.
4) Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.
Dust or foreign substances may get on the product while using it.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and go to the hospital immediately if swallowed.

Uses

Uses:

Disinfection of hands and skin

Directions

Directions (for Gel type)

Take an appropriate amount on your hands and rub thoroughly to dry.

Directions (for Spray type)
Spray the appropriate amount on your hands and rub thoroughly.

PACKAGE LABEL - ZERO Hand Sanitizer 60mL Spray

PACKAGE LABEL - ZERO Hand Sanitizer 300mL Gel

PACKAGE LABEL - ZERO Hand Sanitizer 300mL Spray

INGREDIENTS AND APPEARANCE

ZERO HAND SANITIZER 
rosemary, chamomile, melaleuca alternifolia leaf, lavandula angustifolia liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74772-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ROSEMARY (UNII: IJ67X351P9) (ROSEMARY - UNII:IJ67X351P9)	ROSEMARY	1.0 g  in 100 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	1.0 g  in 100 mL
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) (MELALEUCA ALTERNIFOLIA LEAF - UNII:G43C57162K)	MELALEUCA ALTERNIFOLIA LEAF	1.0 g  in 100 mL
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) (LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER - UNII:19AH1RAF4M)	LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER	1.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74772-010-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/01/2020
2	NDC: 74772-010-02	300 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/01/2020
3	NDC: 74772-010-03	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2020

Labeler - FORMULA (695075306)

Registrant - FORMULA (695075306)

Establishment
Name	Address	ID/FEI	Business Operations
Daraeworld Co., Ltd.		689900025	manufacture(74772-010)