NOBLROSE FOAM CLEANSER- allantoin liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)
Available from:
AMAROS CO., LTD.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Skin Protectant Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the morning or evening.
Authorization status:
OTC monograph final
Authorization number:
60899-070-01

NOBLROSE FOAM CLEANSER- allantoin liquid

AMAROS 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.

----------

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Sodium Laureth Sulfate, PEG-7 Glyceryl Cocoate, Cocamidopropyl Betain,

Lauramide DEA, Glycerin, Butylene Glycol, Polysorbate20, Panthenol, Caprylyl Glycol,

Caprylhydroxamic Acid, Rose Flower Oil, Disodium EDTA, CI 14700, Methylchloroisothiazolinone,

Methylisothiazolinone Mixed Solution, Citric Acid, Fragrance.

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. In case of having following symptoms after using this product, you're advised to stop

using it immediately. If you keep using it, the symptoms will get worse and need to consult a

dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during

usage. 2) In case of having the same symptoms above on the part you put this product on by direct

sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case

of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of babies and children.

INDICATIONS AND USAGE

Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature

is extremely hot or low and exposed to the direct sunlight. 3. Use it in the morning or evening.

DOSAGE AND ADMINISTRATION

Dosage and Administration: Foam Cleansing is a cleanser and make up remover in one. Wet your face

with water. Pump 2 or 3 pumps of foaming cleanser into the palms of your hands. Rub the cleanser

gently into your skin in circular motion with fingertips. Wash off the cleanser by splashing water onto

your face. Dab face dry with a clean towel.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NOBLROSE FOAM CLEANSER

allantoin liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 8 9 9 -0 70

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Alla nto in (UNII: 344S277G0 Z) (ALLANTOIN - UNII:344S277G0 Z)

Alla nto in

0 .75 mg in 150 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Glycerin (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 8 9 9 -0 70 -0 1 150 mL in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 1/20 13

AMAROS CO., LTD.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 9 /0 1/20 13

Labeler -

AMAROS CO., LT D. (690338801)

Registrant -

AMAROS CO., LT D. (690338801)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

AMAROS CO., LTD.

6 9 0 338 8 0 1

ma nufa c ture (6 0 8 9 9 -0 70 )

Revised: 4/2019

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