FLUOCINOLONE ACETONIDE 0.01% / NIACINAMIDE 4% cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)

Available from:

Sincerus Florida LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

FLUOCINOLONE ACETONIDE 0.01% / NIACINAMIDE 4%- FLUOCINOLONE ACETONIDE
0.01% /
NIACINAMIDE 4% CREAM
SINCERUS FLORIDA 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._
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FLUOCINOLONE ACETONIDE 0.01% / NIACINAMIDE 4%
DIRECTIONS FOR USE
SINCERUS FLORIDA, LLC ADVERSE REACTIONS.
ACTIVE, INACTIVE
NDC 72934-2081-2
FLUOCINOLONE ACETONIDE 0.01% / NIACINAMIDE 4%
CREAM 30GM.
FLUOCINOLONE ACETONIDE 0.01% / NIACINAMIDE 4%
fluocinolone acetonide 0.01% / niacinamide 4 % cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:729 34-20 8 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
FLUO CINO LO NE ACETO NIDE (UNII: 0 CD5FD6 S2M) (FLUOCINOLONE
ACETONIDE -
UNII:0 CD5FD6 S2M)
FLUOCINOLONE
ACETONIDE
0 .0 1 g
in 10 0 g
NIACINAMIDE (UNII: 25X51I8 RD4) (NIACINAMIDE - UNII:25X51I8 RD4)
NIACINAMIDE
4 g in 10 0 g
PRODUCT CHARACTERISTICS
COLOR
white
S CORE
S HAP E
S IZ E
FLAVOR
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:729 34-20 8 1-
2
30 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n
Pro duc t
0 5/13/20 19
Sincerus Florida LLC
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 5/13/20 19
LABELER -
Sincerus Florida LLC (080105003)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Sincerus Flo rida LLC
0 8 0 10 50 0 3
ma nufa c ture (729 34-20 8 1)
Revised: 5/2019