INDULGENCE/PROPOWER- benzalkonium chloride soap

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

U S Chemical Corporation

INN (International Name):

BENZALKONIUM CHLORIDE

Composition:

BENZALKONIUM CHLORIDE 2.5 mg in 1 L

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibacterial Agent For handwashing to decrease bacteria on skin.

Authorization status:

OTC monograph not final

Summary of Product characteristics

INDULGENCE/PROPOWER- BENZALKONIUM CHLORIDE SOAP
U S CHEMICAL CORPORATION
_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._
----------
US CHEM F213F
Benzalkonium Chloride 0.13% w/w
Antibacterial Agent
For handwashing to decrease bacteria on skin.
FOR EXTERNAL USE ONLY.
AVOID CONTACT WITH EYES. In case of contact, flush with plenty of
water.
STOP USE AND ASK A DOCTOR IF irritation or rash appears and persists.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center right away. ​EMERGENCY TELEPHONE: [phone]
To decrease bacteria on skin, apply small amount, covering hands with
product for 30
seconds. Add water, lather, rinse.
Water, cocamidopropyl betaine, cocamidopropyl PG-dimonium chloride
phosphate, PEG-
6 cocamide, laurtrimonium chloride, aloe barbadensis leaf juice,
tocopheryl acetate
(vitamin E), fragrance, iodopropynyl butylcarbamate,
methylisothiazolinone, yellow 5, red
33.
INDULGENCE/PROPOWER
benzalkonium chloride soap
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:61307-213
ROUTE OF ADMINISTRATION
TOPICAL
U S Chemical Corporation
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
2.5 mg
in 1 L
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1