FRESH PEAR FOAMING HAND- triclosan solution
Blue Cross Laboratories, Inc.

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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Fresh Pear Antibacterial foaming hand soap

Active ingredient purpose
Triclosan 0.46% Antibacterial

Uses: decrease bacteria on the skin

Keep out of reach of children

If irritation occurs discontinue use of product.

warnings: for external use only
Avoid eye contact. If contact occurs rinse thoroughly with water.
In case of accidental ingestion, get medical help or contact Poison Control Center immediately.

Directions: pump foam into hands, lather vigorously and rinse.

Inactive: water, sodium Laureth Sulfate, Dipropylene glycol, glycerin, sodium PCA, Ammonium Lauryl Sulfate,
cocamidopropyl betaine, polyquaternium 10, fragrance, disodium phosphate, cetearyl alcohol,
aloe barbadensis leaf juice, citric acid, methylparaben, propylparaben, green 3, yellow 10.

Antibacterial foaming hand soap
Fresh Pear

7.5 FL OZ (222 mL)

FRESH PEAR FOAMING HAND
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:22431-528
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.46 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:22431-528-01	222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2011	08/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/23/2011	08/01/2017

Labeler - Blue Cross Laboratories, Inc. (008298879)

Registrant - Blue Cross Laboratories, Inc. (008298879)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Liyuan Daily Chemical Products		530766098	manufacture(22431-528)

Revised: 9/2017

Document Id: 92dfc7a2-8e86-4c09-b967-b1058e8711e1

Set id: e94af0c1-93b2-487d-a0b2-943b1cb55237

Version: 9

Effective Time: 20170906

Blue Cross Laboratories, Inc.