Skin n Skin Co., Ltd. - Protect By Hand Sanitizer Water (Ethanol)

PROTECT BY HAND SANITIZER WATER (ETHANOL)- ethyl ethanol liquid
Skin n Skin Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alcohol

PURIFIED WATER, GLYCERIN, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ROSA CENTIFOLIA FLOWER WATER, CITRUS AURANTIUM DULCIS (ORANGE) OIL

antiseptic

keep out of reach of the children

pour a small amount into hands, spread evenly and rub into the skin

For external use only. Flammable. Keep away from heat or flame.

Do not use

in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

for external use only

PROTECT BY HAND SANITIZER WATER (ETHANOL)
ethyl ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74674-0006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	35 mL in 50 mL

Ingredient Name	Strength
Inactive Ingredients
ORANGE OIL (UNII: AKN3KSD11B)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CHAMOMILE (UNII: FGL3685T2X)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74674-0006-1	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/01/2020

Labeler - Skin n Skin Co., Ltd. (631090037)

Registrant - Skin n Skin Co., Ltd. (631090037)

Name	Address	ID/FEI	Business Operations
Establishment
Skin n Skin Co., Ltd.		631090037	manufacture(74674-0006) , label(74674-0006) , pack(74674-0006)