FDA.reportPublic FDA data

Puriface Hydrogel Cleansing Foam

Manufacturer
iMode Korea, Inc. | JINCOSTECH Co., Ltd.
Effective date
2019-02-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:32

Label at a glance#

ProductPuriface Hydrogel Cleansing Foam
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

Sebum control

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

salicylic acid 0.01%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

Sebum control

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hydrogel foam draft label with drug factshydrogel foam draft label with drug facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2117381salicylic acid 0.01 % Medicated Liquid SoapPSN2
2117381salicylic acid 0.1 MG/ML Medicated Liquid SoapSCD2
2117381salicylic acid 0.01 % Medicated Liquid SoapSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71727-105-022021-01-29C16284748780-1ba0f9c33-361b-a910-e053-dadaa90a0b85Puriface Hydrogel Cleansing Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71727-105-01Puriface Hydrogel Cleansing Foam120 g in 1 TUBEGEL1202
71727-105-02Puriface Hydrogel Cleansing Foam1 in 1 BOXGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71727-105PURIFACE HYDROGEL CLEANSING FOAM (SALICYLIC ACID) GEL [IMODE KOREA, INC.]2Legacy NDC, 2 package rows20190212_8168ab9c-b55c-d39f-e053-2991aa0ad7fd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71727-10571727-105-01, 71727-105-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
816a6c6d-faae-41d0-e053-2a91aa0a4b408168ab9c-b55c-d39f-e053-2991aa0ad7fd2019-02-08WarningsExact identifier
spl id: 816a6c6d-faae-41d0-e053-2a91aa0a4b40
spl set id: 8168ab9c-b55c-d39f-e053-2991aa0ad7fd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.