ANTIBACTERIAL HAND WASH FRESH CITRUS SCENTED- benzalkonium chloride gel
Ganzhou Olivee Cosmetic Co., 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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Hand Wash

Drug Facts

Active ingredient

Benzalkonium Chloride 0.1500%

Purpose

Antibacterial

USE

Helps eliminate bacteria on hands

warnings:

For external use only.

When using this product, avoid contact with eyes; in case of contact, flush eyes with water

Stop use and ask a doctor if irritation or redness develops and persists.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply onto wet hands working into a lather. Rinse thorougly.

Inactive ingredients

Water (Aqua), Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Hydroxethylcellulose, Fragrance (Parfum), Phenoxyethanol, Bezyl Alcohol, Glycerin, Citric Acid, Tocopheryl Acetate (Vitamin E), Ascorbic Acid (Vitamin C), Citrus Aurantium Dulicis (Orange) Oil. May contain: FD &C Red No. 4 (C.I. 14700), FD&C Yellow No. 5 (C.I. 19140), FD&C Blue No. 1 (C.I. 42090), FD&C Red No.33 (C.I. 17200).

Hand wash

label image

ANTIBACTERIAL HAND WASH FRESH CITRUS SCENTED
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56136-394
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERIN (UNII: PDC6A3C0OX)
ACETYLTRIETHYL CITRATE (UNII: 5WBR36T90E)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56136-394-01	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/09/2020

Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)

Name	Address	ID/FEI	Business Operations
Establishment
Ganzhou Olivee Cosmetic Co., Ltd.		543008195	manufacture(56136-394)