AFTATE HYDROCORTISONE CREAM- hydrocortisone cream cream

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Fáanlegur frá:

Sabel Med LLC

INN (Alþjóðlegt nafn):

HYDROCORTISONE ACETATE

Samsetning:

HYDROCORTISONE ACETATE 1 g in 100 g

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

OTC DRUG

Leyfisstaða:

OTC monograph not final

Vara einkenni

AFTATE HYDROCORTISONE CREAM- HYDROCORTISONE CREAM CREAM
SABEL MED LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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HYDROCORTISONE CREAM USP 1% 1 OZ
AFTATE HYDROCORTISONE CREAM
hydrocortisone cream cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 356 -20 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -
UNII:WI4X0 X7BPJ)
HYDROCORTISONE
ACETATE
1 g
in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
MINERAL O IL (UNII: T5L8 T28 FGP)
CETETH-2 0 (UNII: I8 35H2IHHX)
EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)
CHLO RO CRESO L (UNII: 36 W53O710 9 )
SO DIUM METABISULFITE (UNII: 4VON5FNS3C)
PETRO LATUM (UNII: 4T6 H12BN9 U)
Sabel Med LLC
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:70 356 -20 1-0 1
28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
0 5/0 1/20 16
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt348
0 5/0 1/20 16
LABELER -
Sabel Med LLC (091476000)
Revised: 3/2016