GIRLS RULE THE WORLD ANTIBACTERIAL HAND WASH BERRY SCENTED- benzalkonium chloride liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Ganzhou Olivee Cosmetic Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
56136-516-01

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GIRLS RULE THE WORLD ANTIBACTERIAL HAND WASH BERRY SCENTED-

benzalkonium chloride liquid

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, Decyl Glucoside, Cocamidopropylamine Oxide Peg-80

Glyceryl Cocoate, Fragrance (Parfum), Phenoxyethanol, Benzyl Alcohol, Peg-15 Distearate, Glycol

Distearate, Sodium Chloride, Citric Acid. 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

GIRLS RULE THE WORLD ANTIBACTERIAL HAND WASH BERRY SCENTED

benzalkonium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:56 136 -516

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1.5 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

CO CAMIDO PRO PYLAMINE O XIDE (UNII: M4SL8 2J7HK)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

GLYCERIN (UNII: PDC6 A3C0 OX)

ACETYLTRIETHYL CITRATE (UNII: 5WBR36 T9 0 E)

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

GLYCO L DISTEARATE (UNII: 13W7MDN21W)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

PEG-8 0 GLYCERYL CO CO ATE (UNII: A7D0 4GUR0 Z)

Other Ingredients

Ganzhou Olivee Cosmetic Co., Ltd.

Ingredient Kind

Ingredient Name

Quantity

May co ntain

FD&C RED NO . 4 (UNII: X3W0 AM1JLX)

May co ntain

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

May co ntain

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

May co ntain

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:56 136 -516 -0 1 350 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/27/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

11/27/20 20

Labeler -

Ganzhou Olivee Cosmetic Co., Ltd. (543008195)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ganzho u Olivee Co smetic Co ., Ltd.

5430 0 8 19 5

ma nufa c ture (56 136 -516 )

Revised: 11/2020

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