ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 1% gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C), ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF), BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Available from:

Sincerus Florida, LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 1%- ADAPALENE
0.1% /
BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 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._
----------
ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 1%
DIRECTIONS FOR USE
SINCERUS FLORIDA, LLC. ADVERSE REACTIONS
ACTIVE AND INACTIVE
NDC 72934-1002-2 ADAPALENE USP 0.1% / BENZOYL PEROXIDE USP 2.5% /
CLINDAMYCIN USP 1%. GEL 30GM
ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / CLINDAMYCIN 1%
adapalene 0.1% / benzoyl peroxide 2.5% / clindamycin 1% gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:729 34-10 0 2
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CLINDAMYCIN PHO SPHATE (UNII: EH6 D7113I8 ) (CLINDAMYCIN - UNII:3U0
2EL437C)
CLINDAMYCIN
PHOSPHATE
1 g in 10 0 g
ADAPALENE (UNII: 1L48 0 6 J2QF) (ADAPALENE - UNII:1L48 0 6 J2QF)
ADAPALENE
0 .1 g
in 10 0 g
BENZO YL PERO XIDE (UNII: W9 WZN9 A0 GM) (BENZOYL PEROXIDE -
UNII:W9 WZN9 A0 GM)
BENZOYL PEROXIDE
2.5 g
in 10 0 g
PRODUCT CHARACTERISTICS
COLOR
white
S CORE
S HAP E
S IZ E
FLAVOR
IMPRINT CODE
CONTAINS
Sincerus Florida, LLC
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:729 34-10 0 2-
2
30 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n
Pro duc t
0 5/10 /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 5/10 /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 34-10 0 2)
Revised: 6/2020