ANTIBACTERIAL BODY WASH - triclosan liquid

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

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Active ingredient:
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)
Available from:
CVS Pharmacy
INN (International Name):
TRICLOSAN
Composition:
TRICLOSAN 0.15 mL in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For washing to decrease bacteria on the skin.
Authorization status:
OTC monograph not final
Authorization number:
59779-805-18

ANTIBACTERIAL BODY WASH - triclosan liquid

CVS Pharmacy

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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Drug Facts

Active Ingredient

Triclosan 0.15%

Purpos e

Antibacterial

USES

For washing to decrease bacteria on the skin.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOPS.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON

CONTROL CENTER IMMEDIATELY.

DIRECTIONS

SQUEEZE A SMALL AMOUNT ONTO A WET WASHCLOTH, SPONGE, POUF OR HANDS AND

APPLY TO BODY. WORK INTO A RICH LATHER AND RINSE OFF.

QUESTIONS OR COMMENTS?

1-800-746-7287

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-8, FRAGRANCE,

GLYCERIN, ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE, POLYQUATERNIUM-10,

COCAMIDOPROPYL PG-DIMONIUM CHLORIDE, DMDM HYDANTOIN, CITRIC ACID,

TETRASODIUM EDTA, SODIUM CHLORIDE, BLUE 1 (CI42090), RED 33 (CI 17200).

ANTIBACTERIAL BODY WASH

triclosan liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 779 -8 0 5

Route of Administration

TOPICAL

CVS Pharmacy

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TRICLO SAN (UNII: 4NM50 39 Y5X) (TRICLOSAN - UNII:4NM50 39 Y5X)

TRICLOSAN

0 .15 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

PO LYETHYLENE GLYCO L 9 0 0 (UNII: UEP8 43BRCQ)

GLYCERIN (UNII: PDC6 A3C0 OX)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

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

EDETATE SO DIUM (UNII: MP1J8 420 LU)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

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

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

ISO STEARAMIDO PRO PYL MO RPHO LINE LACTATE (UNII: 0 8 2Y3WQI5K)

PO LYQ UATERNIUM-10 ( 4 0 0 CPS AT 2 %) (UNII: HB140 1PQFS)

CO CAMIDO PRO PYL PG-DIMO NIUM CHLO RIDE PHO SPHATE (UNII: H2KVQ74JM4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 779 -8 0 5-18

532 mL in 1 BOTTLE, PLASTIC

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

0 6 /27/20 11

Labeler -

CVS Pharmacy (062312574)

Registrant -

Apollo Health and Beauty Care (201901209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo llo Health and Beauty Care

20 19 0 120 9

ma nufa c ture

Revised: 6/2011

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