ANTIBACTERIAL- triclosan soap
Cintas Corp

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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Drug Facts

Active ingredient

Triclosan 0.5%

Uses

For hand washing to decrease bacteria on skin

Recommended for repeated use

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions:

Wet hands.

Apply product and work into a lather.

Rinse well and dry hands thoroughly.

Inactive ingredients:

Water, Sodium lauryl sulfate, Sodium laureth sulfate, Cocamidopropyl betaine, Cocamide MEA, Glycerin, Propylene glycol, Sodium chloride, DMDM hydantoin, Fragrance, Citric acid.

Purpose

Antimicrobial

Sanis

Antibacterial

Spray Soap

800 ML 27.0 FL OZ

container label

ANTIBACTERIAL
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42961-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X)	Triclosan	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Sodium Laureth Sulfate (UNII: BPV390UAP0)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Chloride (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DMDM Hydantoin (UNII: BYR0546TOW)
COCO MONOETHANOLAMIDE (UNII: C80684146D)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42961-007-02	800 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/25/2020	01/17/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/24/2010	01/17/2022

Labeler - Cintas Corp (056481716)

Name	Address	ID/FEI	Business Operations
Establishment
Camco Chemicals Company Inc		004238366	manufacture(42961-007)

Revised: 1/2022

Document Id: 02f0bc4d-7817-45e2-8264-81d06f58bf7d

Set id: a7b2119e-5f3b-42e6-9cea-4a881532b5ef

Version: 10

Effective Time: 20220120

Cintas Corp