DR.LIBEAUTE THERMAL SPRING WATER- allantoin liquid

Dr.LIBEAUTE Thermal Spring Water by

Drug Labeling and Warnings

Dr.LIBEAUTE Thermal Spring Water by is a Otc medication manufactured, distributed, or labeled by Ongoong Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

allantoin

INACTIVE INGREDIENT

water, glycerin, butylene glycol, etc.

PURPOSE

skin protecttant, hydrate

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

clean face and pat dry.

pour toner onto the soft side onf pad or your palm and dab over the face, neck, and chest

(please refer to the directions on the label)

WARNINGS

For external use only.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.LIBEAUTE THERMAL SPRING WATER 
allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74084-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74084-0011-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2021
2	NDC: 74084-0011-2	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/30/2021

Labeler - Ongoong Co Ltd (695625965)

Registrant - Ongoong Co Ltd (695625965)

Establishment
Name	Address	ID/FEI	Business Operations
Ongoong Co Ltd		695625965	label(74084-0011) , manufacture(74084-0011)