LEADERS MEDIU CALMING PEPPERMINT PACK- allantoin gel

LEADERS MEDIU CALMING PEPPERMINT PACK by

Drug Labeling and Warnings

LEADERS MEDIU CALMING PEPPERMINT PACK by is a Otc medication manufactured, distributed, or labeled by SANSUNG LIFE & SCIENCE CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.51%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Phaseolus angularis seed powder, Butylene Glycol, Kaolin, Bentonite, Magnesium aluminum silicate, PVP, Cellulose, Caramel, Chromium Oxide greens, Betaine, Titanium dioxide, Aloe barbadensis leaf water, Daucus carota sativa (carrot) root extract, Cucurbita pepo (pumpkin) fruit extract, Disodium EDTA, Mentha piperita (peppermint) oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Chlorphenesin

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Not for human consumption. Discontinue use if irritation occurs. If irritation persists, consult a physician.

Use immediately after opening. Store in cool and dry place. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Directions

Directions: After cleansing face, apply a thin layer of the Wash-Off Pack on the face, leaving out the area around eyes and mouth. Leave on for 5-10 minutes then wash off with tepid water. *Suggested use is 2-3 times a week

Directions

Directions: After cleansing face, apply a thin layer of the Wash-Off Pack on the face, leaving out the area around eyes and mouth. Leave on for 5-10 minutes then wash off with tepid water. *Suggested use is 2-3 times a week

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADERS MEDIU CALMING PEPPERMINT PACK 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69424-450
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	51.0 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ADZUKI BEAN (UNII: 31GYU1X0FP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69424-450-01	10 mL in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/01/2015

Labeler - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)

Registrant - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)

Establishment
Name	Address	ID/FEI	Business Operations
SANSUNG LIFE & SCIENCE CO., LTD.		689524929	manufacture(69424-450)