ANTIBACTERIAL REFRESHING HAND WASH LEMON LIME 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 and redness develops and persists.

Keep out of reach of children.

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

Directions

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

Inactive ingredients

Water (Aqua), Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Hydroxethylcellulose, Fragrance (Parfum), Phenoxyethanol, Bezyl Alcohol, Glycerin, Citric Acid, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, FD&C No. 4 (C.l. 14700), D&C Red No. 33 (Cl 17200), FD&C Yellow 5, FD&C Blue No. 1 (Cl 42090).

package

label image

ANTIBACTERIAL REFRESHING HAND WASH LEMON LIME SCENTED
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56136-376
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)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56136-376-01	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/08/2020

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

Name	Address	ID/FEI	Business Operations
Establishment
Ganzhou Olivee Cosmetic Co., Ltd.		543008195	manufacture(56136-376)