PROTECT BY HAND SANITIZER GEL (ETHANOL)- alcohol gel

Protect By Hand Sanitizer gel (ethanol) by

Drug Labeling and Warnings

Protect By Hand Sanitizer gel (ethanol) by is a Otc medication manufactured, distributed, or labeled by Ken Company Co., Ltd., Skin n Skin Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

alcohol

INACTIVE INGREDIENT

Water
Glycerin
Carbomer
Triethanolamine
Rosmarinus Officinalis (Rosemary) Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Rose Centifolia Flower Water
Citrus Aurantium Dulcis (Orange) Oil
Limonene

PURPOSE

Sterilization of hands and skin

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

Apply an appropriate amount on your hands and rub well to dry.

WARNINGS

1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and
ears, in the oral cavity (may have irritating effects)
2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
2) Skin irritation symptoms
3. Other precautions
1) For external use only (do not underwear).
2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
3) Be careful not to inhale the vapor when using it extensively or for a long period of time (irritation to the
mucous membranes, headaches, etc. may occur if ethanol vapor is consumed in large quantities or repeatedly).
4) If repeated use on the same site, be careful as the skin may become rough due to degreasing.
5) Do not use sealed bandages, cast bandages, packs, etc., as irritation may occur.
6) Do not use this medicine for anal or vaginal compresses as it may cause irritation or chemical burns.
7) Do not use for any other purpose.
4. Precautions for storage
1) Avoid shading and keep in shading.
2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.
3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign
Objects.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROTECT BY HAND SANITIZER GEL (ETHANOL) 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80594-0001
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
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TROLAMINE (UNII: 9O3K93S3TK)
ROSEMARY OIL (UNII: 8LGU7VM393)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
GLYCERIN (UNII: PDC6A3C0OX)
ORANGE OIL (UNII: AKN3KSD11B)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80594-0001-1	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/15/2020

Labeler - Ken Company Co., Ltd. (694883411)

Registrant - Ken Company Co., Ltd. (694883411)

Establishment
Name	Address	ID/FEI	Business Operations
Skin n Skin Co., Ltd.		631090037	manufacture(80594-0001)

Establishment
Name	Address	ID/FEI	Business Operations
Ken Company Co., Ltd.		694883411	label(80594-0001)