BOBBARKER ANTIBACTERIAL BAR- triclosan soap
Jiangsu Xinheyuan Plastic Daily Chemical 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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Active Ingredient

Triclosan 0.16%

Purpose

Antibacterial

Uses

for washing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product

Avoid contact with eyes. In case of eye contact, flush with water.

Don't use this product on infants under 6.

Stop use and ask a doctor

If irritation and redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet bar with water
lather vigorously and wash skin
rinse and dry thoroughly.

Inactive Ingredients

Soap (Sodium Palmate and/or Sodium Tallowate, Sodium Cocoate and/or Sodium Palm Kernelate), Water, Palm Acid, glycerine, sodium chloride, Coconut Acid, Fragrance, Tetrasodium EDTA, Citric Acid Anhydrous

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BOBBARKER ANTIBACTERIAL BAR
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69688-104
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.16 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM PALMATE (UNII: S0A6004K3Z)
CALCIUM CARBONATE (UNII: H0G9379FGK)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PALM ACID (UNII: B6G0Y5Z616)
COCONUT ACID (UNII: 40U37V505D)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69688-104-01	1000 in 1 CASE	08/01/2016
1		11.06 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:69688-104-02	500 in 1 CASE	08/01/2016
2		29.77 g in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:69688-104-03	144 in 1 CASE	08/01/2016
3		81.07 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/01/2016

Labeler - Jiangsu Xinheyuan Plastic Daily Chemical Co., Ltd. (527743312)

Name	Address	ID/FEI	Business Operations
Establishment
Jiangsu Xinheyuan Plastic Daily Chemical Co., Ltd.		527743312	manufacture(69688-104)