PURIFACE HYDROGEL CLEANSING FOAM- salicylic acid gel

Puriface Hydrogel Cleansing Foam by

Drug Labeling and Warnings

Puriface Hydrogel Cleansing Foam by is a Otc medication manufactured, distributed, or labeled by iMode Korea, Inc., JINCOSTECH Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

salicylic acid 0.01%

Purpose

Acne Treatment

Uses

Sebum control

Warnings

Warnings

For external use only

Do not use when

skin is red, inflamed, irritated, or painful

When using this product

§ skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

§ avoid contact with eyes. If contact occurs, flush thoroughly with water.

Stop use and ask a doctor if

§ Rash or irritation on skin develops and lasts

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

Directions

Wet face. Apply to hands, add water and work into a lather. Gently massage all over face avoiding eye area. Rinse thoroughly and pat dry.

Keep out of reach of children

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

Inactive ingredients

Water, Stearic Acid, Glycerin, Myristic Acid, Lauric Acid, Potassium Hydroxide, Beeswax, Glyceryl Stearate, Glycol Stearate, Glycol Distearate, Sodium Chloride, Lavandula Angustifolia (Lavender) Oil, Allantoin, Beta-Glucan, Butylene Glycol, Lavandula Angustifolia (Lavender) Flower Extract, Monarda Didyma Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Xanthan Gum, Ceratonia Siliqua (Carob) Gum, Sucrose, Carrageenan, Potassium Chloride, Gellan Gum, Cellulose Gum, Propanediol, Pentylene Glycol, Cocos Nucifera (Coconut) Fruit Extract, Pinus Sylvestris Leaf Extract, Sodium Hyaluronate, 1,2-Hexanediol, Arginine, Disodium EDTA, Citric Acid, Sodium Citrate, Butyrospermum Parkii (Shea) Butter, Olea Europaea (Olive) Fruit Oil, Hexylene Glycol, Hydroxyacetophenone, Caprylyl Glycol, Ethylhexylglycerin.

Puriface Hydrogel Cleansing Foam

INGREDIENTS AND APPEARANCE

PURIFACE HYDROGEL CLEANSING FOAM 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71727-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.012 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71727-105-02	1 in 1 BOX	02/08/2019
1	NDC: 71727-105-01	120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/08/2019

Labeler - iMode Korea, Inc. (694627846)

Registrant - iMode Korea, Inc. (694627846)

Establishment
Name	Address	ID/FEI	Business Operations
JINCOSTECH Co., Ltd.		688484870	manufacture(71727-105)

Establishment
Name	Address	ID/FEI	Business Operations
iMode Korea, Inc.		694627846	relabel(71727-105)