ACCOJE SUNSCREEN (SPF50 BROAD SPECTRUM)- zinc oxide cream

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

זמין מ:

Ucl Co., Ltd.

INN (שם בינלאומי):

ZINC OXIDE

הרכב:

ZINC OXIDE 4.97 g in 100 mL

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

OTC DRUG

סממני תרפויטית:

for skin protectant apply proper amount to the skin

מצב אישור:

OTC monograph final

מאפייני מוצר

ACCOJE SUNSCREEN (SPF50 BROAD SPECTRUM)- ZINC OXIDE CREAM
UCL 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._
----------
DRUG FACTS
zinc oxide 4.97%
water, titanium dioxide, dimethicone, glycerin, etc.
for skin protectant
keep out of reach of the children
apply proper amount to the skin
1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and
symptopms of hypersnesitivity occur
dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the
symptoms are servere, seek medical
advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low
humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of
children
for external use only
ACCOJE SUNSCREEN (SPF50 BROAD SPECTRUM)
zinc oxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 574-0 0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
4.9 7 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
Ucl Co., Ltd.
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
WATER (UNII: 0 59 QF0 KO0 R)
DIMETHICO NE (UNII: 9 2RU3N3Y1O)
GLYCERIN (UNII: PDC6 A3C0 OX)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:70 574-0 0 0 1-1
6 0 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
0 3/0 1/20 16
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 rt