PARMA ANUS SKIN PREMIUM CLEANSER- allantoin gel

Parma Anus Skin Premium Cleanser by

Drug Labeling and Warnings

Parma Anus Skin Premium Cleanser by is a Otc medication manufactured, distributed, or labeled by PARMA KOREA.CO.LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Allantoin 0.3%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Anus Cleansing

DOSAGE & ADMINISTRATION

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

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PARMA ANUS SKIN PREMIUM CLEANSER 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71614-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
MANDELIC ACID (UNII: NH496X0UJX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
OLEIC ACID (UNII: 2UMI9U37CP)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIGLYCERIN (UNII: 3YC120743U)
SODIUM COCOATE (UNII: R1TQH25F4I)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
NEPIDERMIN (UNII: TZK30RF92W)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
RICE BRAN (UNII: R60QEP13IC)
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
MUNG BEAN (UNII: 1LIB31N73G)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
PURSLANE (UNII: M6S840WXG5)
RHEUM PALMATUM ROOT (UNII: G025DAL7CE)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
ASIAN GINSENG (UNII: CUQ3A77YXI)
POLYSORBATE 85 (UNII: A7F3N56197)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71614-002-02	1 in 1 CARTON	08/27/2018
1	NDC: 71614-002-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/27/2018

Labeler - PARMA KOREA.CO.LTD (694857393)

Registrant - PARMA KOREA.CO.LTD (694857393)

Establishment
Name	Address	ID/FEI	Business Operations
PARMA KOREA.CO.LTD		694857393	manufacture(71614-002)