BOBBARKER ANTIBACTERIAL WRAPPED BODY- benzethonium chloride soap
Yangzhou H&R 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

Benzethonium Chloride 0.1%

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 months of age.

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, Glycerin, Sodium Chloride, Coconut Acid, Fragrance, Tetrasodium EDTA, Citric Acid Anhydrous

label image

BOBBARKER ANTIBACTERIAL WRAPPED BODY
benzethonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72797-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PALM ACID (UNII: B6G0Y5Z616)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCONUT ACID (UNII: 40U37V505D)
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72797-001-01	1000 in 1 BOX	01/13/2023
1		11.06 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:72797-001-02	500 in 1 BOX	01/13/2023
2		29.78 g in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:72797-001-03	144 in 1 BOX	01/13/2023
3		81.04 g in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:72797-001-04	144 in 1 BOX	01/13/2023
4		85.07 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	01/13/2023

Labeler - Yangzhou H&R Plastic Daily Chemical Co., Ltd. (554455648)

Name	Address	ID/FEI	Business Operations
Establishment
Yangzhou H&R Plastic Daily Chemical Co., Ltd.		554455648	manufacture(72797-001)