PARMA ANUS SKIN PREMIUM CLEANSER- allantoin gel 
PARMA KOREA.CO.LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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71614-002_Parma Anus Skin Premium Cleanser

Allantoin 0.3%

Skin Protectant

Anus Cleansing

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.

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

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

image description

PARMA ANUS SKIN PREMIUM CLEANSER 
allantoin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71614-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71614-002-021 in 1 CARTON08/27/2018
1NDC:71614-002-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/27/2018
Labeler - PARMA KOREA.CO.LTD (694857393)
Registrant - PARMA KOREA.CO.LTD (694857393)
Establishment
NameAddressID/FEIBusiness Operations
PARMA KOREA.CO.LTD694857393manufacture(71614-002)

Revised: 1/2023
Document Id: f16cf75f-0e63-510e-e053-2995a90aec97
Set id: 9694aea6-db34-409e-b4fb-4d4fe6fd33fa
Version: 4
Effective Time: 20230104
 
PARMA KOREA.CO.LTD