PROTECT ANTIBACTERIAL BAR- triclosan soap
Boya Biotechnology Company Limited

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(s)

Triclosan 0.3%

Purpose

Antiseptic

Use

Decrease bacteria on the skin

Warnings

For external use only.

Stop use and ask a doctor if redness or irritation develops and persist for more than 72 hours

Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply to skin while bathing or washing

Rinse and repeat

Inactive ingredients

Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Fragrance, Sodium Chloride, Disodium EDTA, CI 19140, CI 42090, CI 14700, CI 17200

Package Label - Principal Display Panel

image description

PROTECT ANTIBACTERIAL BAR
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73885-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISODIUM HEDTA (UNII: KME849MC7A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73885-002-01	140 g in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/26/2020

Labeler - Boya Biotechnology Company Limited (403701144)

Name	Address	ID/FEI	Business Operations
Establishment
Boya Biotechnology Company Limited		403701144	manufacture(73885-002)