FDA.reportPublic FDA data

Parma Anus Skin Premium Cleanser

Manufacturer
PARMA KOREA
Effective date
2025-10-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:15:37

Label at a glance#

ProductParma Anus Skin Premium Cleanser
Active ingredientALLANTOIN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.3%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

Anus Cleansing

DOSAGE & ADMINISTRATION SECTION

Wet anal area thoroughly.

Apply an appropriate amount of the product to anal area. Massage anus and maintain 30 seconds. Rinse with water for 60 seconds.

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin.

Rinse with water to remove.

Stop use and ask a doctor if rash or irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INACTIVE INGREDIENT SECTION

Water
Hydroxyethylcellulose
Black Strap Powder
Mandelic Acid
Disodium EDTA
Oleic Acid
Lauryl Glucoside
Butylene Glycol
Diglycerin
Sodium Cocoate
Cocamide MIPA
sh-Oligopeptide-1
Acetyl Hexapeptide-8
Shea Butteramidopropyl Betaine
Sodium Cocoamphoacetate
Oryza Sativa (Rice) Bran Extract
Artemisia Vulgaris Extract
Phaseolus Radiatus Seed Extract
Centella Asiatica Extract
Portulaca Oleracea Extract
Crataegus Oxyacantha Extract
Rheum Palmatum Root Extract
Bambusa Vulgaris Extract
Eucalyptus Globulus Leaf Extract
Hamamelis Virginiana (Witch Hazel) Extract
Chamomilla Recutita (Matricaria) Flower/Leaf Extract
Propolis Extract
Sapindus Mukorossi Fruit Extract
Panax Ginseng Root Extract
Polysorbate 85
1,2-Hexanediol
Caprylic/Capric Triglyceride
Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71614-002-022024-11-25C16284748780-19d75b9d0-3664-f424-e053-dadaa90a57ce71614-002_Parma Anus Skin Premium Cleanser
71614-002-022024-07-30C16284748780-19d75b9d0-3664-f424-e053-dadaa90a57ce71614-002_Parma Anus Skin Premium Cleanser
71614-002-022024-01-30C16284748780-19d75b9d0-3664-f424-e053-dadaa90a57ce71614-002_Parma Anus Skin Premium Cleanser
71614-002-022021-12-15C16284748780-19d75b9d0-3664-f424-e053-dadaa90a57ce71614-002_Parma Anus Skin Premium Cleanser
71614-002-022020-01-31C16284748780-19d75b9d0-3664-f424-e053-dadaa90a57ce71614-002_Parma Anus Skin Premium Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71614-002-01Parma Anus Skin Premium Cleanser100 mL in 1 BOTTLEGEL1006
71614-002-02Parma Anus Skin Premium Cleanser1 in 1 CARTONGEL16

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71614-00271614-002-01, 71614-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
SAPINDUS MUKOROSSI FRUIT66H9NW427YIACT
ASIAN GINSENGCUQ3A77YXIIACT
POLYSORBATE 85A7F3N56197IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALLANTOIN344S277G0ZACTIB
WATER059QF0KO0RIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
MANDELIC ACIDNH496X0UJXIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
OLEIC ACID2UMI9U37CPIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIGLYCERIN3YC120743UIACT
SODIUM COCOATER1TQH25F4IIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
NEPIDERMINTZK30RF92WIACT
ACETYL HEXAPEPTIDE-8L4EL31FWILIACT
SODIUM COCOAMPHOACETATEW7Q5E87674IACT
RICE BRANR60QEP13ICIACT
ARTEMISIA VULGARIS ROOT32MP823R8SIACT
MUNG BEAN1LIB31N73GIACT
CENTELLA ASIATICA7M867G6T1UIACT
PURSLANEM6S840WXG5IACT
RHEUM PALMATUM ROOTG025DAL7CEIACT
BAMBUSA VULGARIS TOPFIW80T6P6VIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
PROPOLIS WAX6Y8XYV2NOFIACT

Source Document#

Source XML

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
Parma Anus Skin Premium CleanserALLANTOINPARMA KOREA9694aea6-db34-409e-b4fb-4d4fe6fd33fa2025-10-02WarningsExact identifier
ndc (package): 71614-002-01
ndc (package): 71614-002-02
ndc (product): 71614-002
ndc11 (package): 71614000202
ndc11 (package): 71614000201
spl id: 4035f2d2-bc4b-63c3-e063-6294a90a751e
spl set id: 9694aea6-db34-409e-b4fb-4d4fe6fd33fa

Reported adverse events (FAERS/openFDA)#

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