ANTIBACTERIAL 2X- triclosan liquid

Antibacterial by

Drug Labeling and Warnings

Antibacterial by is a Otc medication manufactured, distributed, or labeled by Sante Manufacturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient - Triclosan 0.115%

PURPOSE

Purpose - Antibacterial

INDICATIONS & USAGE

Uses - for handwashing to decrease bacteria on the skin

WARNINGS

Warning For external use only

STOP USE

Stop use and ask a doctor if irritation or redness develops

WHEN USING

When using this product do not get into eyes. If contact occurs, rinse eye thoroughly with water

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• Wet hands
• apply palmful to hands
• scrub thoroughly
• rinse

INACTIVE INGREDIENT

Water, Sodium Laureth Sulfate, Sodium Chloride, DMDM Hydantoin, Citric Acid, Fragrance, EDTA, Yellow # 5, Red# 33

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL  2X
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71020-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1.15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETIC ACID (UNII: 9G34HU7RV0)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71020-009-64	1900 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/19/2016

Labeler - Sante Manufacturing Inc (242048747)

Establishment
Name	Address	ID/FEI	Business Operations
Sante Manufacturing Inc		242048747	manufacture(71020-009)