HYDRO-STASIS cyclosporine-a liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)

Available from:

DR MARC'S MANUFACTURING AND SALES

INN (International Name):

CYCLOSPORINE

Composition:

CYCLOSPORINE 0.0005 g in 100 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

HYDRO-STASIS- CYCLOSPORINE-A LIQUID
DR MARC'S MANUFACTURING AND SALES
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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USE:
FOR TOPICAL APPLICATION TO THE EYE.
ACTIVE:
CYCLOSPORINE-A 5 PPM
USUAL DOSAGE:
INSTILL ONE DROP TWICE DAILY IN EACH EYE, APPROXIMATELY 12 HOURS
APART.
INACTIVES:
GLYCERIN USP, PROPYLENE GLYCOL USP, CELLULOSE, WATER, PRESERVATIVE
STORAGE:
STORE AT 15-25°C (59-77°F)
HYDRO-STASIS
cyclosporine-a liquid
DR MARC'S MANUFACTURING AND SALES
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:70 414-20 2
ROUTE OF ADMINISTRATION
OPHTHALMIC
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CYCLO SPO RINE (UNII: 8 3HN0 GTJ6 D) (CYCLOSPORINE - UNII:8 3HN0 GTJ6
D)
CYCLOSPORINE
0 .0 0 0 5 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
GLYCERIN (UNII: PDC6 A3C0 OX)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
PO WDERED CELLULO SE (UNII: SMD1X3XO9 M)
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70 414-20 2-
11
10 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n
Pro duc t
0 7/13/20 17
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
0 2/23/20 16
LABELER -
DR MARC'S MANUFACT URING AND SALES (084006446)
Revised: 9/2017