REBORNCARE HAND SANITIZER (500ML)- ethyl alcohol gel

Reborncare hand sanitizer (500mL) by

Drug Labeling and Warnings

Reborncare hand sanitizer (500mL) by is a Otc medication manufactured, distributed, or labeled by Reborncare, Venice Cosmetic, Reborncare Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingedient

Ethanol (ethyl alcohol) (70%)

Purpose

Antibacterial

Uses

Hand sanitizer for decreasing bacteria on skin

Warnings

For external use only

Do not use if you are allergic to any of the ingredients

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. avoid contact with broken, irritated, or itching skin. Do not puncture or incinerate.

Stop use and ask a doctor if irritation or redness develops and the condition persists for more than 72 hours.

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Apply the adequate amount on hands

Inactive ingredients

Water, Glycerin, Tocopheryl

Reborncare hand sanitizer (500mL)

INGREDIENTS AND APPEARANCE

REBORNCARE HAND SANITIZER (500ML) 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79486-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79486-102-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/07/2020

Labeler - Reborncare (695538808)

Establishment
Name	Address	ID/FEI	Business Operations
Venice Cosmetic		695047082	manufacture(79486-102)

Establishment
Name	Address	ID/FEI	Business Operations
Reborncare Co., Ltd.		695520618	manufacture(79486-102)