CRUSADER ULTRA SKIN LIGHTENING- hydroquinone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE), PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)

Available from:

International Beauty Exchange

INN (International Name):

HYDROQUINONE

Composition:

HYDROQUINONE 1.14 g in 57 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

On children under 12 years of age unless directed by a doctor Skin Lightener

Authorization status:

OTC monograph not final

Summary of Product characteristics

CRUSADER ULTRA SKIN LIGHTENING - HYDROQUINONE CREAM
INTERNATIONAL BEAUTY EXCHANGE
_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._
----------
DRUG FACTS
Hydroquinone 2%
Padimate O, 0.5%
For external use only
On children under 12 years of age unless directed by a doctor
Avoid contact with eyes.
Skin Lightener
CRUSADER ULTRA SKIN LIGHTENING
hydroquinone cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 6 129 -210
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
HYDRO Q UINO NE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)
HYDROQUINONE
1.14 g in 57 g
PADIMATE O (UNII: Z110 0 6 CMUZ) (PADIMATE O - UNII:Z110 0 6 CMUZ)
PADIMATE O
.28 5 g in 57 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERYL STEARATE CITRATE (UNII: WH8 T9 2A0 6 5)
CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)
GLYCERIN (UNII: PDC6 A3C0 OX)
ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)
ALLANTO IN (UNII: 344S277G0 Z)
ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)
SO DIUM METABISULFITE (UNII: 4VON5FNS3C)
SO DIUM CITRATE (UNII: 1Q73Q2JULR)
SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)
EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PRO PYLPARABEN (UNII: Z8 IX2SC1OH)
CHLO RO CRESO L (UNII: 36 W53O710 9 )
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:6 6 129 -210 -39
57 g in 1 TUBE
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 rt358 A
0 1/0 1/20 11
LABELER -
International Beauty Exchange (966261273)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
JABONES PARDO SA
46 20 18 250
ma nufa c ture
International Beauty