PRO RADIANCE RENASCENT AN INFINITE ENERGIZER- glycerin emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Shine&Shine Co.,Ltd

INN (International Name):

GLYCERIN

Composition:

GLYCERIN 6 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

skin protectant apply proper amount to the skin

Authorization status:

OTC monograph final

Summary of Product characteristics

PRO RADIANCE RENASCENT AN INFINITE ENERGIZER - GLYCERIN EMULSION
SHINE&SHINE 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
glycerin
water, butylene glycol, allantoin etc.
skin protectant
keep out of reach of the children
apply proper amount to the skin
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.
If the product gets into the eyes, don't rub but rinse with water.
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
PRO RADIANCE RENASCENT AN INFINITE ENERGIZER
glycerin emulsion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 0 6 7-10 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
6 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)
PACKAG ING
Shine&Shine Co.,Ltd
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:70 0 6 7-10 0 1-1 130 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio
n Pro duct
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 3/20 15
LABELER -
Shine&Shine Co.,Ltd (689517119)
REGISTRANT -
Shine&Shine Co.,Ltd (689517119)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Shine&Shine Co .,Ltd
6 8 9 517119
ma nufa c ture (70 0 6 7-10 0 1)
Revised: 9/2015