IMIQUIMOD 5% / SALICYLIC ACID 30% / TRETINOIN 0.1% gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ), TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R), IMIQUIMOD (UNII: P1QW714R7M) (IMIQUIMOD - UNII:P1QW714R7M)

Available from:

Sincerus Florida, LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

IMIQUIMOD 5% / SALICYLIC ACID 30% / TRETINOIN 0.1%- IMIQUIMOD 5% /
SALICYLIC ACID
30% / TRETINOIN 0.1% GEL
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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IMIQUIMOD 5% / SALICYLIC ACID 30% / TRETINOIN 0.1%
DIRECTIONS FOR USE
SINCERUS FLORIDA. ADVERSE REACTIONS
ACTIVE, INACTIVE
NDC 72934-1128-2 IMIQUIMOD USP 5% / SALICILIC ACID USP 30%/ TRETINOIN
USP
0.1%. GEL 30 GM.
IMIQUIMOD 5% / SALICYLIC ACID 30% / TRETINOIN 0.1%
imiquimod 5% / salicylic acid 30% / tretinoin 0.1% gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:729 34-1128
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
SALICYLIC ACID
30 g in 10 0 g
TRETINO IN (UNII: 56 8 8 UTC0 1R) (TRETINOIN - UNII:56 8 8 UTC0 1R)
TRETINOIN
0 .1 g in 10 0 g
Sincerus Florida, LLC
IMIQ UIMO D (UNII: P1QW714R7M) (IMIQUIMOD - UNII:P1QW714R7M)
IMIQUIMOD
5 g in 10 0 g
PRODUCT CHARACTERISTICS
COLOR
ye llo w
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 34-1128 -
2
30 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n
Pro duc t
0 5/0 7/20 19
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 5/0 7/20 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 34-1128 )
Revised: 5/2019