CHI-MYST TOPICAL- chitosan ketorolac bupivacaine suspension spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO), KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L), CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) (UNII: SBD1A2I75N) (CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) - UNII:SBD1A2I75N)

Available from:

Prescription Care LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

CHI-MYST TOPICAL- CHITOSAN KETOROLAC BUPIVACAINE SUSPENSION SPRAY,
METERED
PRESCRIPTION CARE LLC
_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._
----------
CHI-MYST TOPICAL SPRAY
DRUG INFORMATION
CHI-MYST TOPICAL
chitosan ketorolac bupivacaine suspension spray, metered
Prescription Care LLC
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:70 48 6 -0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BUPIVACAINE HYDRO CHLO RIDE (UNII: 7TQO7W3VT8 ) (BUPIVACAINE -
UNII:Y8 33539 4RO)
BUPIVACAINE
HYDROCHLORIDE
ANHYDROUS
0 .3 g
in 10 0 mL
KETO RO LAC TRO METHAMINE (UNII: 4EVE59 46 BQ) (KETOROLAC -
UNII:YZI510 5V0 L)
KETOROLAC
0 .3 g
in 10 0 mL
CHITO SAN LO W MO LECULAR WEIGHT ( 2 0 -2 0 0 MPA.S) (UNII:
SBD1A2I75N)
(CHITOSAN LOW MOLECULAR WEIGHT (20 -20 0 MPA.S) - UNII:SBD1A2I75N)
CHITOSAN LOW MOLECULAR
WEIGHT (20 -20 0 MPA.S)
0 .1 g
in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
GLYCERIN (UNII: PDC6 A3C0 OX)
0 .3 mL in 10 0 mL
WATER (UNII: 0 59 QF0 KO0 R)
10 0 mL in 10 0 mL
LACTIC ACID LACTATE, DL- (UNII: N37QW3EK1L)
0 .14 mL in 10 0 mL
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
0 .0 45 g in 10 0 mL
PACKAG ING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING
START DATE
MARKETING
END DATE
1
NDC:70 48 6 -
0 0 1-0 0
10 0 mL in 1 BOTTLE, SPRAY; Type 9 : Other Type o f Part 3 Co mbinatio
n Pro duct
(e.g., Drug/Device/Bio lo gical Pro duct)
0 8 /19 /20 16
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 8 /19 /20 16
LABELER -
Prescription Care LLC (080059076)
REGISTRANT -
Prescription Care LLC (080059076)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Prescriptio n Care LLC
0 8 0 0 59 0 76
ma nufa c ture (70 48 6 -0 0 1)
Revised: 8/2016