ANTIBACTERIAL 2X- triclosan liquid
Sante Manufacturing 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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Active Ingredient - Triclosan 0.115%

Purpose - Antibacterial

Uses - for handwashing to decrease bacteria on the skin

Warning For external use only

Stop use and ask a doctor if irritation or redness develops

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

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

Directions

Wet hands
apply palmful to hands
scrub thoroughly
rinse

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

Spa Soap Antibacterial 2X

ANTIBACTERIAL 2X
triclosan liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Sante Manufacturing Inc (242048747)

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