AROCELL PURE CLEANSING PADS by FICC Co., Ltd. / ANCORS CO., LTD.

Drug Details [pdf]

AROCELL PURE CLEANSING PADS- glycerin swab
FICC 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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ACTIVE INGREDIENTS

Glycerin 8.0%

INACTIVE INGREDIENTS

Water, Polyglyceryl-6 Caprylate, Polyglyceryl-10 Laurate, Cymbopogon Schoenanthus Extract, Chamomilla Recutita (Matricaria) Flower Extract, Centella Asiatica Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Houttuynia Cordata Extract, Camellia Sinensis Leaf Extract, Dipropylene Glycol, Caprylyl Glycol,Butylene Glycol, 1,2-Hexanediol, Sodium Citrate, Dipotassium Glycyrrhizate, Citric Acid, Disodium EDTA, Hydroxyacetophenone

PURPOSE

Skin protectant

WARNINGS

For external use only
Consult a specialist if there are abnormal symptoms or side effects such as redness, swelling or itchiness due to direct sunlight during or after use.
Avoid using on wounded areas.
Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps protect your skin.

Directions

■ Wipe gently with an embossing side to remove makeup and dirt. Turn the pad over to the soft side and wipe again to finish.

Other Information

■ Keep away from direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AROCELL PURE CLEANSING PADS
glycerin swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81647-090
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	Glycerin	0.08 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
POLYGLYCERYL-6 CAPRYLATE (UNII: DGV8R54VG7)
Polyglyceryl-10 Laurate (UNII: MPJ2Q8WI8G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81647-090-01	70 in 1 CARTON; Type 0: Not a Combination Product	03/01/2021	08/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/01/2021	08/15/2021

Labeler - FICC Co., Ltd. (695721074)

Registrant - FICC Co., Ltd. (695721074)

Name	Address	ID/FEI	Business Operations
Establishment
ANCORS CO., LTD.		688494804	manufacture(81647-090)

Revised: 9/2021

Document Id: a454564e-d8ed-4a4e-a589-eb0b4355fed3

Set id: 3c0fd4b3-f50a-41f9-8b73-f8c4eb574420

Version: 2

Effective Time: 20210901