SOFTSOAP ANTIBACTERIAL SPARKLING PEAR- 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:
Colgate-Palmolive
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antibacterial helps eliminate bacteria on hands
Authorization status:
OTC monograph not final
Authorization number:
35000-102-11

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SOFTSOAP ANTIBACTERIAL SPARKLING PEAR- benzalkonium chloride liquid

Colgate-Palmolive

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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Softsoap Antibacterial Sparkling Pear

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpos e

Antibacterial

Us e

helps eliminate bacteria on hands

Warnings

For external use only.

When using this product, avoid contact with eyes.

In case of contact, flush with water.

Keep out of reach of children, except under adult supervision. If swallowed, get medical help or

contact a Poison Control Center right away.

Directions

Wet hands and apply soap. Lather front and back, between your fingers, and under your nails. Scrub for

at least 20 seconds, rinse then dry.

Inactive ingredients

Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Sodium Chloride, Cocamide

MEA, Fragrance, PEG-120 Methyl Glucose Dioleate, Citric Acid, Tetrasodium EDTA,

Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Yellow 5.

Ques tions ?

1-800-255-7552

DIST. BY:

COLGATE-PALMOLIVE COMPANY,

NEW YORK, NY 10022 USA

PRINCIPAL DISPLAY PANEL - 332 mL Bottle Label

®

Softsoap

brand

Antibacterial

Gentle Clean

LEAVES SKIN FEELING SOFT

ELIMINATES 99.9% OF BACTERIA*

Sparkling Pear

Hand Soap

With Moisturizers

11.25 FL OZ

(332 mL)

0013088

SOFTSOAP ANTIBACTERIAL SPARKLING PEAR

benzalkonium chloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:350 0 0 -10 2

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

1.33 mg

in 1 mL

Colgate -Palmolive

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CETRIMO NIUM CHLO RIDE (UNII: UC9 PE9 5IBP)

GLYCERIN (UNII: PDC6 A3C0 OX)

LAURAMIDO PRO PYLAMINE O XIDE (UNII: I6 KX16 0 QTV)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

CO CO MO NO ETHANO LAMIDE (UNII: C8 0 6 8 4146 D)

PEG-12 0 METHYL GLUCO SE DIO LEATE (UNII: YM0 K6 4F20 V)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

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

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:350 0 0 -10 2-11 332 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/16 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part333E

11/16 /20 20

Labeler -

Colgate-Palmolive (001344381)

Revised: 11/2020

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