LAVENDER ANTIBACTERIAL- benzalkonium chloride soap
Tropical Degil Cosmetics Industries LTD

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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Tropical Degil lavender antibacterial soap

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product avoid contact with eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritaion or redness develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poiston Control Center right away.

Directions

Pump into hands, wet as needed
Lather for at least 15 seconds
Rinse and dry thoroughly

Inactive ingredients

Cetrimonium Chloride, Cocamide MEA, Cocamidopropylamine Oxide, Fragrance, Glycerin, Lauramine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-120 Methyl Glucose Dioleate, Sodium Chloride, Red 4, Violet 2, Water.

Prinicpal Display Panel

Antibacterial Soap

Lavender Scented

10 fl oz 300 ml

Front Panel

LAVENDER ANTIBACTERIAL
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62685-120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1755 g in 135 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62685-120-01	135 g in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020
2	NDC:62685-120-02	225 g in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/01/2020

Labeler - Tropical Degil Cosmetics Industries LTD (600437230)

Name	Address	ID/FEI	Business Operations
Establishment
Tropical Degil Cosmetics Industries LTD		600437230	manufacture(62685-120)