Label: PARMA ANUS SKIN PREMIUM CLEANSER- allantoin gel
- NDC Code(s): 71614-002-01, 71614-002-02
- Packager: PARMA KOREA.CO.LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated January 4, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- 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
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INGREDIENTS AND APPEARANCE
PARMA ANUS SKIN PREMIUM CLEANSER
allantoin gelProduct 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)
