POWER PLAY- chloroxylenol soap

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

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Active ingredient:
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)
Available from:
Superior Chemical Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
53125-765-04, 53125-765-76

POWER PLAY- chloroxylenol soap

Superior Chemical Corporation

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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Power Play

Power Play

Active Ingredient

Chloroxylenol 0.5%

Power Play

Uses

Antibacterial hand cleaner.

Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

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Warnings

For external use only.

Avoid contact with eyes.

Children under the age of 6 should be supervised by an adult when using this product.

Discontinue use is irritation or redness develops.

If irritation persists for more than 72 hours, consult a physician.

KEEP OUT OF REACH OF CHILDREN.

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Directions

Read the entire label before using this product.

Dispense 1-2 pumps of product onto wet palm.

Lather and rinse hands with clean water

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Inactive Ingredients

Water, Sodium Lauryl lSulfate, Coco Diethanolimide, Cocamidopropyl Betaine, Phenoxyethanol,

Sodium Laureth Sulfate, Allantoin, DMDM Hydantoin, Fragrance, Aloe Barbadensis Leaf Juice,

Glycerine, FD&C Yellow #5, FD&C Red #40.

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Questions or Comments?Phone: (800) 777-9343

MDS information: (800) 891-4965

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Purpose

Antibacterial

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KEEP OUT OF REACH OF CHILDREN

Power Play

Factory Stuff

76544 PowerPlay

76576-00 Factory Stuff

POWER PLAY

chloroxylenol soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:53125-76 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHLO RO XYLENO L (UNII: 0 F32U78 V2Q) (CHLOROXYLENOL - UNII:0 F32U78 V2Q)

CHLOROXYLENOL

5 mg in 1 mL

Inactive Ingredients

Superior Chemical Corporation

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

CO CO DIETHANO LAMIDE (UNII: 9 20 0 5F9 72D)

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

ALLANTO IN (UNII: 344S277G0 Z)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:53125-76 5-

378 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

11/12/20 12

2

NDC:53125-76 5-

250 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

11/12/20 12

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

11/12/20 12

Labeler -

Superior Chemical Corporation (023335086)

Registrant -

Betco corporation, Ltd. (005050158)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Betco Co rpo , Ltd.

0 0 50 50 158

ma nufa c ture (53125-76 5)

Revised: 4/2019

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