INDULGENCE/PROPOWER- benzalkonium chloride soap

Indulgence/ProPower by

Drug Labeling and Warnings

Indulgence/ProPower by is a Otc medication manufactured, distributed, or labeled by U S Chemical Corporation, Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride 0.13% w/w

PURPOSE

Antibacterial Agent

INDICATIONS & USAGE

For handwashing to decrease bacteria on skin.

WARNINGS

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. ​EMERGENCY TELEPHONE: 1-866-923-4913

DOSAGE & ADMINISTRATION

To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INDULGENCE/PROPOWER 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61307-213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM 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	NDC: 61307-213-41	1 L in 1 BAG; Type 0: Not a Combination Product	01/30/2017
2	NDC: 61307-213-10	1 L in 1 BAG; Type 0: Not a Combination Product	01/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/30/2017

Labeler - U S Chemical Corporation (031457842)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(61307-213)