MACCOLA- glycerin soap
NATURE REPUBLIC 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 INGREDIENT

Active Ingredient: Glycerin 20%

INACTIVE INGREDIENT

Inactive Ingredients:
SOAP NOODLES, Aspergillus/Rice Ferment Extract, GRAPE SEED OIL, Kyounin Yu, Marin Collagen, CASTOR SEED OIL, Schizandra Chinensis Fruit Extract

PURPOSE

Purpose: This mild soap provides a firm, full lather that removes impurities from the skin, leaving skin feeling soft and moisturized after washing.

WARNINGS

Cautions:
For external use only.
Avoid contact with eyes and mouth.
Discontinue use if signs of irritation or rash appear.
Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

How to Use:
Gently work into a lather.
Apply lather to face and rub in gentle circular motion.
Rinse with water.

DOSAGE AND ADMINISTRATION

How to Use:
Gently work into a lather.
Apply lather to face and rub in gentle circular motion.
Rinse with water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MACCOLA
glycerin soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-165
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX)	Glycerin	12 g in 60 g

Ingredient Name	Strength
Inactive Ingredients
GRAPE SEED OIL (UNII: 930MLC8XGG)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-165-01	60 g in 1 CARTON; Type 0: Not a Combination Product	11/01/2011	12/30/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/01/2011	12/30/2017

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Name	Address	ID/FEI	Business Operations
Establishment
NATURE REPUBLIC CO., LTD.		631172020	manufacture(51346-165)

Revised: 8/2018

Document Id: 6e7e402d-05d5-4e35-a772-1b5f84ad9869

Set id: 8e65ff51-e27b-46be-bcc1-3121c879e556

Version: 2

Effective Time: 20180823

NATURE REPUBLIC CO., LTD.