Label: MACOMA SENIOR PREMIUM CLEANSER- allantoin gel
- NDC Code(s): 71614-003-01, 71614-003-02
- 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
Lauramidopropyl Betaine
Hyaluronic Acid
Sodium Cocoamphoacetate
Methyl Hydroxyethylcellulose
Acetyl Hexapeptide-8
Disodium EDTA
Lauryl Glucoside
Betula Alba Juice
Olea Europaea (Olive) Fruit Extract
Hydrolyzed Collagen
Trehalose
Centella Asiatica Extract
Butylene Glycol
Diglycerin
Oryza Sativa (Rice) Bran Extract
Hamamelis Virginiana (Witch Hazel) Extract
Bambusa Vulgaris Extract
Curcuma Longa (Turmeric) Root Extract
Artemisia Vulgaris Extract
Arctium Lappa Root Extract
Hippophae Rhamnoides Extract
Rheum Palmatum Root Extract
Eucalyptus Globulus Leaf Extract
Citrus Aurantium Bergamia (Bergamot) Fruit Extract
Lavandula Angustifolia (Lavender) Flower Extract
Sapindus Mukorossi Fruit Extract
Pelargonium Graveolens Extract
Panax Ginseng Root Extract
Mentha Piperita (Peppermint) Extract
Propolis Extract
Mandelic Acid
Tocopheryl Acetate
Ascorbic Acid
Polysorbate 85
1,2-Hexanediol
Caprylic/Capric Triglyceride - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MACOMA SENIOR PREMIUM CLEANSER
allantoin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71614-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233) HYALURONIC ACID (UNII: S270N0TRQY) SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) HYMETELLOSE (50 MPA.S) (UNII: 0MGW7Q3QG4) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) BETULA PUBESCENS RESIN (UNII: 9G931M6I4G) BLACK OLIVE (UNII: 2M6QWV94OC) TREHALOSE (UNII: B8WCK70T7I) CENTELLA ASIATICA (UNII: 7M867G6T1U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIGLYCERIN (UNII: 3YC120743U) RICE BRAN (UNII: R60QEP13IC) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V) TURMERIC (UNII: 856YO1Z64F) ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) RHEUM PALMATUM ROOT (UNII: G025DAL7CE) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) BERGAMOT OIL (UNII: 39W1PKE3JI) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y) ASIAN GINSENG (UNII: CUQ3A77YXI) MENTHA PIPERITA (UNII: 79M2M2UDA9) PROPOLIS WAX (UNII: 6Y8XYV2NOF) MANDELIC ACID (UNII: NH496X0UJX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) 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:71614-003-02 1 in 1 CARTON 01/04/2023 1 NDC:71614-003-01 660 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 01/04/2023 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(71614-003)
