MACOMA SENIOR PREMIUM CLEANSER- allantoin gel
PARMA KOREA.CO.LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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71614-001_Macoma Senior Premium Cleanser

Allantoin 1%

Skin Protectant

Body Cleansing

Push out adequate amount of MACOMA Cleanser and apply it on shower towel or hands. Make fluent bubble scrub and massage from hair to body and wash out with warm water.

Consult with dermatologiest when there is any symptom such as erythema, swelling, irritation and esnsitization.

Immediately wash off when it is in mouth or eyes.

Keep out of reach of children

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

image description

MACOMA SENIOR PREMIUM CLEANSER
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71614-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71614-001-02	1 in 1 CARTON	08/27/2018	11/16/2022
1	NDC:71614-001-01	660 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/27/2018	11/16/2022

Labeler - PARMA KOREA.CO.LTD (694857393)

Registrant - PARMA KOREA.CO.LTD (694857393)

Name	Address	ID/FEI	Business Operations
Establishment
PARMA KOREA.CO.LTD		694857393	manufacture(71614-001)

Revised: 11/2022

Document Id: ed9ac320-de58-ea3b-e053-2a95a90abb99

Set id: c85de446-0850-42bd-82fa-b02d3f9757ed

Version: 12

Effective Time: 20221116

PARMA KOREA.CO.LTD