SELLA NATURAL BABY- glycerin lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)

Available from:

Sella Natural Cosmetics Co.,Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

skin protectant apply to the skin and rub gently and wash away

Authorization status:

OTC monograph final

Summary of Product characteristics

SELLA NATURAL BABY - GLYCERIN LOTION
SELLA NATURAL COSMETICS 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
glycerine
water, butylene glycol, panthenol etc
skin protectant
keep out of reach of the children
apply to the skin and rub gently and wash away
Stop using the product when you have skin problems or the product
disagrees with your skin
Stop using the product immediately and consult a dermatologist if you
have redness, swelling, itching
or irritation on the skin while or after using the product.
Don't place the product in any place where it will be subjected to
extremely high or low temperatures
or direct sunlight.
for external use only
SELLA NATURAL BABY
glycerin lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 6 0 3-0 8 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)
GLYCERIN
0 .4 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
Sella Natural Cosmetics Co.,Ltd.
WATER (UNII: 0 59 QF0 KO0 R)
BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)
PANTHENO L (UNII: WV9 CM0 O6 7Z)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 9 6 0 3-0 8 0 1-1
120 mL in 1 BOTTLE
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
12/0 1/20 14
LABELER -
Sella Natural Cosmetics Co.,Ltd. (687563333)
REGISTRANT -
Sella Natural Cosmetics Co.,Ltd. (687563333)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Sella Natural Co smetics Co .,Ltd.
6 8 756 3333
ma nufa c ture (6 9 6 0 3-0 8 0 1)
Revised: 2/2015